Inspection Technician

Assistant Manager, HRBP

Logistics Supervisor

Logistics Analyst

IAD / SAD / LAD GCP Data Engineer

Customer Service Specialist- Malaysia

Supply Chain Analyst II

Production Technician I

Structural Engineer

Quality Associate I

Role Description: <ul><li>Purpose Statement The Inspection Technician is responsible for sterile pharmaceutical inspection operations, with additional expectations for technical troubleshooting, routine maintenance, and active support of qualification activities.</li><li>This position operates in an isolator-based manufacturing environment, works with high potent APIs and controlled substances, and plays a key role in ensuring compliance with cGMP, safety, and site procedures.</li><li>The Inspection Technician serves as a technical resource within the production team and supports continuous improvement of manufacturing processes.</li><li>This position will include cross training for support of formulation, IV Bag filling, leak inspection, dispensing and packaging.</li></ul> Responsibilities: <ul><li>Operate, monitor, and adjust IV Bag inspection equipment and direct 100% inspection of filled IV-bags of various sizes and configuration.</li><li>Secondary responsibilities will include operating manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform visual inspection of final product to ensure conformance with quality standards and specifications.</li><li>Perform AQL testing manually to verify integrity of the automated inspection system.</li><li>Serve as first-line troubleshooting support for equipment and GMP manufacturing issues, escalating to engineering or maintenance as required.</li><li>Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.</li><li>Assist in the creation, revision, and implementation of SOPs and production-related procedures.</li><li>Provide training, guidance, and on-the-job support to other production personnel.</li><li>Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.</li><li>Review documentation completed by fellow members of the production team.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications/Experience <ul><li>High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.</li><li>Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of product post fill inspection.</li><li>Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with skills including the ability to concisely describe problems to mechanics.</li><li>Knowledge of cGMP, and aseptic processing, requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI required. Experience with a supervisory controller and data acquisition system (SCADA) interface will be a plus.</li><li>Experience with isolator-based manufacturing strongly preferred.</li><li>Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols</li></ul> Skills/Competencies <ul><li>Precise skills for inspecting finished product effectively.</li><li>Demonstrated problem-solving and troubleshooting skills.</li><li>Ability to mentor and train less experienced technicians.</li><li>Excellent attention to detail and documentation accuracy.</li><li>Effective communication and teamwork skills.</li><li>Commitment to safety, quality, and data integrity.</li><li>Comfortable working in cleanroom environments with PPE requirements.</li></ul>

Responsibilities: Talent Acquisition &amp; Onboarding: <ul><li>Coordinate end-to-end technician hiring logistics, including assessment day scheduling, candidate communication, medical checks, and offer documentation.</li><li>Execute onboarding activities for new technicians by preparing onboarding packs, coordinating induction schedules, and tracking completion of documentation (EPF, SOCSO, tax forms, uniform issuance).</li><li>Maintain and update TA trackers and dashboards, including time-to-fill, offer acceptance rates, and onboarding completion.</li><li>Support salaried recruitment coordination as needed, including interview scheduling, candidate communication, and documentation.</li></ul> Communication &amp; Engagement: <ul><li>Execute plant-wide communication and engagement activities, including town halls, floor walks, and recognition programs (certificates, gifts, and communications).</li><li>Support employee engagement survey administration by distributing surveys, tracking participation rates, consolidating feedback, and supporting action-planning sessions.</li><li>Maintain engagement trackers and ensure timely follow-up on action items.</li></ul> Employee Lifecycle Management: <ul><li>Manage HR administration across the full employee lifecycle, including new hire documentation, probation tracking, contract renewals, transfers, promotions, and exit documentation.</li><li>Coordinate employee exit processes, including clearance forms, exit interviews, and final settlement coordination with HR Operations.</li><li>Maintain accurate employee records and ensure HRIS data integrity, including updates in SuccessFactors.</li></ul> People Analytics &amp; Reporting: <ul><li>Maintain core HR dashboards covering attrition, time-to-fill, onboarding completion, and probation status.</li><li>Prepare weekly and monthly HR review decks for leadership.</li><li>Support ad hoc HR data requests and analysis.</li></ul> General HR: <ul><li>Respond to employee queries related to HR policies, benefits, leave balances, and HR processes.</li><li>Maintain HR notice boards and plant HR communication materials, ensuring information accessibility and accuracy.</li><li>Support HR audits (ERSA and internal compliance checks) by preparing required documentation and tracking closure of audit findings.</li></ul> Requirements: <ul><li>4–6 years of HR experience, preferably in manufacturing, FMCG, or large-scale frontline environments.</li><li>Strong foundation in HR operations, talent acquisition coordination, onboarding, and employee lifecycle management.</li><li>Hands-on experience with HRIS systems such as SAP, SuccessFactors, or similar platforms.</li><li>Strong data management and reporting capabilities.</li><li>Proficiency in Microsoft Excel (pivot tables, VLOOKUP, dashboards) and Microsoft PowerPoint.</li><li>High attention to detail with strong organizational and multitasking skills.</li><li>Ability to operate effectively in a fast-paced, high-volume environment with shifting priorities.</li><li>Process-oriented mindset with a focus on continuous improvement and simplification.</li><li>Diploma or Bachelor’s degree in Human Resource Management, Business Administration, or a related discipline.</li></ul>

Responsibilities: Team Leadership and Management <ul><li>Lead and supervise logistics and Imports/Exports teams, providing guidance, training, and support to ensure efficient execution of all logistics activities.</li><li>Foster a positive team culture that promotes collaboration, continuous learning, and operational excellence.</li></ul> Shipment and Freight Coordination <ul><li>Oversee the scheduling and coordination of inbound and outbound shipments to meet production and customer requirements.</li><li>Coordinate international shipments from all regions to Latin America, maintaining close communication with service providers to track orders and ensure service level compliance.</li></ul> Warehouse and Plant Operations <ul><li>Manage warehouse and plant logistics operations to ensure efficient material flow and optimal inventory handling.</li><li>Monitor and control distribution and logistics-related costs.</li></ul> Cross-functional Collaboration and Project Management <ul><li>Collaborate with cross-functional teams to develop and implement logistics strategies aligned with organizational objectives.</li><li>Coordinate supply chain projects and/or lead logistics team members in managing regional initiatives within the LAR region.</li><li>Work closely with internal stakeholders, external partners, and regulatory authorities to ensure project objectives are achieved, including but not limited to:</li><li>New Resale Operations: Assess feasibility and support implementation, ensuring supply chain efficiency and regulatory compliance.</li><li>Transportation Mode Expansion: Evaluate alternative transportation modes (e.g., cabotage) to optimize routes and reduce costs.</li><li>Warehousing Projects: Support the establishment and management of warehouses, ensuring compliance with regulations and efficient storage and distribution.</li><li>Market Analysis: Conduct research to identify logistics trends, opportunities, and potential partnerships.</li><li>Project Planning: Develop project plans, budgets, and timelines, ensuring effective execution.</li><li>Risk Assessment: Identify potential risks and propose mitigation strategies.</li><li>Documentation and Compliance: Ensure all permits, licenses, and documentation are obtained and maintained in line with regional and international regulations.</li><li>Reporting and Evaluation: Monitor project progress, report results, and evaluate business impact on logistics and supply chain operations.</li></ul> Compliance and Safety <ul><li>Manage the Imports/Exports team responsible for customs clearance, international transportation, and trade documentation.</li><li>Collaborate with external customs brokers to ensure accurate and timely submission of documentation.</li><li>Ensure full compliance with regulatory, trade, and company standards.</li><li>Support internal and external audits by providing accurate and timely information.</li><li>Promote safety by ensuring compliance with all applicable safety standards and legal requirements.</li></ul> Supplier and Service Provider Management <ul><li>Maintain regular communication with logistics suppliers and service providers.</li><li>Review supplier performance, investigate and resolve shipment-related issues, and ensure timely and reliable deliveries.</li></ul> Cost Control and Reporting <ul><li>Prepare and analyze logistics and trade-related reports, providing insights and recommendations to senior management.</li><li>Utilize data analytics and predictive tools to optimize logistics operations strategically.</li><li>Manage logistics process documentation and flowcharts with a focus on continuous improvement, productivity, and cost efficiency.</li></ul> Requirements: <ul><li>Bachelor’s degree in Supply Chain Management, Business, Engineering, or a related field (preferred).</li><li>Solid experience in logistics and/or other supply chain functions, including a minimum of 3 years in a leadership role.</li><li>Strong knowledge of customs regulations and logistics operations, including transportation, distribution, and warehousing.</li><li>Proven experience in global logistics operations, international trade, or supply chain management.</li><li>Excellent communication and interpersonal skills to work effectively with internal teams, external partners, and government authorities.</li><li>Strong analytical skills with the ability to interpret data, identify trends, and make informed decisions.</li><li>Proficiency in ERP systems (e.g., SAP) for logistics and trade management.</li><li>Detail-oriented mindset with a strong focus on accuracy and compliance.</li><li>Demonstrated problem-solving abilities to address operational challenges and implement effective solutions.</li><li>Professional certifications such as Six Sigma (Green or Black Belt), ISO 9001, Lean Management, APICS CSCP, or PMP are desirable.</li><li>Fluency in Portuguese and English is required; proficiency in Spanish is an advantage.</li></ul>

Responsibilities: Transportation Management <ul><li>Schedule and coordinate inbound and outbound transportation activities.</li><li>Monitor transportation providers’ performance to ensure on-time and cost-effective deliveries.</li><li>Optimize routing and logistics strategies to minimize transportation costs and improve efficiency.</li></ul> Warehouse Communication <ul><li>Maintain regular communication with warehouse teams to ensure timely receipt, storage, and dispatch of materials.</li><li>Conduct audits and inventory reviews to ensure accuracy and compliance.</li><li>Collaborate with warehouse teams to resolve discrepancies, delays, or operational issues.</li></ul> Material Handling <ul><li>Oversee the receipt, inspection, and verification of materials.</li><li>Coordinate proper storage, handling, and retrieval of materials.</li><li>Ensure compliance with safety, quality, and operational standards.</li></ul> Billing and Invoicing <ul><li>Manage logistics-related billing processes, ensuring invoice accuracy and completeness.</li><li>Investigate and resolve billing discrepancies with suppliers and service providers.</li><li>Maintain accurate records of invoices, payments, and related documentation.</li></ul> Customer Complaint Resolution <ul><li>Address customer complaints related to logistics and supply chain operations in a timely and professional manner.</li><li>Conduct root cause analysis and implement corrective and preventive actions.</li><li>Collaborate with customer service and internal teams to ensure customer satisfaction.</li></ul> Automation Processes <ul><li>Develop and implement automation solutions, including macros, robots, and custom code, to improve logistics and supply chain processes.</li><li>Identify opportunities for automation, process optimization, and efficiency improvements.</li><li>Collaborate with cross-functional teams to integrate automation solutions across systems and operations.</li></ul> Dashboard Development and Maintenance <ul><li>Design, develop, and maintain dashboards using tools such as Power BI and Power Automate to track key performance indicators (KPIs).</li><li>Ensure data accuracy, consistency, and relevance in reports and dashboards.</li><li>Work with stakeholders to gather requirements and support data-driven decision-making.</li></ul> Safety and Compliance <ul><li>Respond to internal and external audits, ensuring accurate and timely compliance reporting.</li><li>Ensure adherence to company policies, local regulations, and international standards related to transportation and storage.</li><li>Promote and maintain compliance with all applicable safety, legal, and regulatory requirements.</li></ul> Business Development and Project Coordination <ul><li>Participate in and coordinate regional strategic business development initiatives, including but not limited to:</li><li>New Resale Operations: Assess feasibility and support implementation of new resale operations in collaboration with cross-functional teams.</li><li>Transportation Mode Expansion: Evaluate alternative transportation modes, such as cabotage, to improve efficiency and reduce costs.</li><li>Warehouse Operations: Support the establishment and management of warehouses, ensuring regulatory compliance and operational efficiency.</li><li>Market Analysis: Conduct market research to identify trends, opportunities, and potential partnerships aligned with supply chain growth objectives.</li><li>Project Planning: Develop project plans, budgets, timelines, and track execution with key stakeholders.</li><li>Risk Assessment: Identify risks associated with new initiatives and propose mitigation strategies.</li><li>Documentation and Compliance: Ensure all required permits, licenses, and regulatory documentation are obtained and maintained.</li><li>Stakeholder Collaboration: Work with internal teams, external partners, and government agencies to facilitate approvals and successful implementation.</li><li>Reporting and Evaluation: Monitor, report, and evaluate project performance and its impact on logistics and supply chain operations.</li></ul>&nbsp;Requirements: Qualifications <ul><li>Bachelor’s degree in Logistics, Engineering, Supply Chain Management, or a related field (preferred).</li><li>Proven experience in logistics, transportation, or supply chain operations.</li><li>Strong analytical, problem-solving, and organizational skills.</li><li>Excellent communication and interpersonal abilities.</li><li>Knowledge of quality management systems and standards (ISO 9000, ISO 14000, IATF, etc.).</li><li>Proficiency in logistics systems and Microsoft Office applications.</li><li>Hands-on experience with automation tools, macros, custom code, and dashboard development using Power BI and Power Automate.</li><li>Ability to work in a fast-paced environment and manage multiple priorities effectively.</li><li>Supply chain certifications (CSCP, CPSM, or similar) are an advantage.</li><li>Fluency in Portuguese and English is required; Spanish proficiency is a plus</li></ul>

Responsibilities: Architecture &amp; Design:&nbsp; <ul><li>Design end-to-end data architectures that integrate real-time streaming (Kafka, GCP Pub/sub) and batch processing (Big Query OR Databricks).</li></ul> Pipeline Development:&nbsp; <ul><li>Build and maintain robust ETL/ELT pipelines flowing into BigQuery/Databricks, ensuring data is clean, modeled, and ready for consumption.</li></ul> Custom Integration:&nbsp; <ul><li>Develop custom APIs and microservices using Java/Python/C# to facilitate data movement between niche systems and the data lakehouse.</li></ul> Infrastructure Management:&nbsp; <ul><li>Deploy and manage data workloads on Google Kubernetes Engine (GKE), ensuring high availability and cost-efficiency.</li></ul> Technical Leadership:&nbsp; <ul><li>Mentor junior engineers, conduct code reviews, and establish DataOps best practices (CI/CD, automated testing, and monitoring).</li></ul> Data Reliability:&nbsp; <ul><li>Implement data quality frameworks to ensure accuracy and lineage across the hybrid environment.</li></ul> Requirements: <ul><li>Experience with Terraform &amp; Azure Dev Ops (ADO).</li><li>Knowledge of workflow orchestrators like Apache Airflow (Cloud Composer).</li><li>Experience implementing Data Governance (metadata management, data cataloging).</li><li>Data Processing &amp; Storage</li><li>BigQuery: Expert-level SQL and experience with partition/cluster optimization.</li><li>Databricks: Deep knowledge of the Lakehouse architecture, Delta Lake, and Spark (PySpark/Scala) Software Engineering &amp; APIs</li><li>Languages: Proficiency in Java/Python/C# for backend development and custom data connectors.</li><li>API Design: Proven ability to build and consume RESTful APIs for data ingestion Streaming &amp; Infrastructure</li><li>Kafka/GCP Pub-Sub: Experience building event-driven architectures and managing producers/consumers.</li><li>GKE: Proficiency in containerization (Docker) and orchestrating data workloads on Kubernetes.</li></ul>

Responsibilities: Quote and Order Management&nbsp; <ul><li>Interface with Customers for Quote request or Price inquiries and approval</li><li>Submit quotation request for pricing team approval.&nbsp;</li><li>Sales order entry, order confirmation &amp; expediting orders.</li><li>Order change and backlog price adjustment</li><li>On-going Backlog Management</li><li>Shipment release and follow up</li><li>Report and support past due backlog reduction</li><li>NPI - follow up with PM/Plant/Finance for part master and cost setup</li><li>Handle Sample order</li><li>Process RMA / Goods replacement</li></ul> Customer Service <ul><li>Handle customer enquiries &amp; complaints. Investigate and work with other departments to resolve customer issues in a timely manner.&nbsp;</li><li>Emails/Conference calls / Customer&nbsp;and company Plant Visits for critical delivery issues, expedition or projects.&nbsp;</li><li>Work out solutions on Customer’s special requirements, such as label, Customs process, packing &amp; etc.&nbsp;</li><li>NPS/VOC/Customer Service Survey Improvement Process. Identify and work on corrective actions to recurring issues.&nbsp;&nbsp;</li></ul> Customer Supply Chain Management&nbsp; <ul><li>Initiate Stock Requisition for customer advance order or buffer stock.</li><li>Work with Planning team on capacity adjustment in order to fulfill Customer’s demands</li><li>Consignment Stock Management/ Customer demand forecast monitoring and accuracy analysis</li><li>Manage customer forecast/demand and inventory level, work with Supply Chain to fulfill customer demand.&nbsp;</li><li>Negotiate with Customer for VMI liability and deadstock compensation.</li><li>Resolve logistics and custom issues with relevant functions</li></ul> Customer Credit and Billing Management <ul><li>Billing attainment</li><li>Follow up queries with Account Receivable</li><li>Coordinate with Finance and Customer to solve pass due invoices issue</li><li>Manage customer credit status &amp; escalate for any abnormal status</li><li>Apply credit release</li><li>Process Credit note / Debit Note</li></ul> Requirements: <ul><li>Bachelor’s degree is any related field.</li><li>Minimum 3 year of industry experience in customer service/order management.</li><li>Customer Focus.</li><li>Excellent communication skill. Able to interact with internal and external partners.</li><li>Problem solving skills</li><li>Team player with positive attitude.</li><li>Proactive, responsible and takes ownership of issues.</li><li>Able to work under pressure.</li><li>Self-motivated, independent and able to work with minimum supervision</li><li>Sense of urgency, analytical and able to multi-task under fast paced environment.</li></ul>

Role Description: <ul><li>Follow demand and capacity analysis, production control, and inventory control of main projects to meet the production, delivery demand, and cost, schedule requirements within the managers direction.</li></ul> Responsibilities: Production control&nbsp; <ul><li>Review resource allocation weekly and production plan monthly and monitor daily output.</li><li>Oversee material supply and ensure smooth production and avoid downtime</li></ul> Delivery performance <ul><li>Review the backlog and analyze the root cause of past due orders; oversee abnormal production status.</li><li>Prepare the related material and initiate the meeting to facilitate the department responsible for solving the issues.</li><li>Communicate with the sales office or other client entities in solving order change issues.</li></ul> Inventory control&nbsp; <ul><li>Checking and analyzing the inventory of raw material, components, and finished goods based on MPS.</li><li>Update MRP to component planner &amp; suppliers</li><li>Review the open purchasing affiliates order and take necessary action. (pull in, pull out, or cancellation); and update the new schedule of open purchasing orders to suppliers and deal with demand/capacity or current production/quality status to ensure smooth production and cost effectiveness.</li></ul> NG(no good) inventory clearance <ul><li>Follow up on block inventory and push owners to solve issues</li><li>Follow RMA closely on time</li></ul> LT reduction&nbsp; <ul><li>Capacity and demand analysis to ensure the LT will be reduced gradually.</li><li>Ensure the LT in SAP is accurate and stable.</li></ul> PO management <ul><li>Create and release PO based on aligned MPS</li><li>Communicate with the operation to ensure PO can be managed timely and accurate manner.</li></ul> Demand &amp; Capacity Analysis <ul><li>Communicate with customers and the global demand team.</li><li>Evaluate demand and capacity status from IBP.</li><li>Review the existing, new project, and migration project schedule to conduct effective control on demand and capacity and ensure resources can be available just in time.</li></ul> MPS (Master Production Schedule) &amp; MRP (Material Requirement Planning)&nbsp; <ul><li>Make MPS based on demand, capacity, stock policy, and material supply status.</li><li>Arrange incoming material and production based on MPS EHS</li><li>Attend EHS training, familiar with the companys emergency response plan.</li><li>Actively participate in and complete the department EHS target.</li></ul> Requirements: <ul><li>Bachelors degree.</li><li>5+ years of planning and working experience in electronics.</li></ul> Key Competencies&nbsp; <ul><li>Good Computer/office software skills, familiar with SAP, strong data processing and analysis.</li><li>Communication skills.</li><li>Open-minded.</li><li>Pressure management skills.</li><li>Teamwork.</li><li>Agility in handling emergencies and deadlines.</li><li>Patience.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment used for formulation, filling, and packaging of IV bag products in compliance with cGMP and SOPs.</li><li>Perform routine preventive maintenance on production equipment to ensure operational readiness and minimize downtime.</li><li>Support equipment and process qualifications, including execution assistance, documentation support, and adherence to qualification protocols.</li><li>Act as first-line troubleshooting support for mechanical or operational equipment issues, escalating to Engineering or Maintenance as required.</li><li>Assist with isolator technology operations, including cleaning, sterilization, and environmental control procedures.</li><li>Participate in line clearance, changeover, and cleaning activities to maintain continuous production operations.</li><li>Accurately complete batch records, logbooks, and production documentation in compliance with data integrity and cGMP requirements.</li><li>Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.</li><li>Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.</li><li>Contribute to continuous improvement initiatives focused on safety, efficiency, and product quality.</li><li>Work closely with cross-functional teams, including Engineering, Validation, and Quality, to support operational readiness.</li><li>Comply with all Environmental Health &amp; Safety (EHS) standards and maintain a clean and safe work environment.</li></ul> Key Stakeholders Internal <ul><li>Production Supervisor and Production Manager</li><li>Engineering and Maintenance</li><li>Validation and Quality Assurance</li><li>Materials and Warehouse Teams</li><li>Environmental Health &amp; Safety (EHS)</li></ul> External <ul><li>Equipment vendors and service technicians (as required)</li></ul> Requirements: Qualifications &amp; Experience <ul><li>High school diploma or equivalent required; Associate degree or technical certification in mechanical, engineering, or life sciences preferred.</li><li>Minimum 2 years of experience in pharmaceutical or other regulated manufacturing environments, including compounding, filling, inspection, or secondary packaging.</li><li>Prior experience with sterile products or IV bag manufacturing strongly preferred.</li><li>Strong mechanical aptitude with the ability to perform routine maintenance and troubleshoot equipment issues.</li><li>Experience operating automated production equipment using HMI or SCADA interfaces required.</li><li>Working knowledge of cGMP, aseptic processing, and controlled substance regulations preferred.</li><li>Ability to read, understand, and follow SOPs, maintenance procedures, and qualification protocols.</li></ul> Skills &amp; Competencies <ul><li>Strong technical and mechanical problem-solving skills</li><li>High attention to detail with a commitment to quality and data integrity</li><li>Ability to work effectively in a fast-paced, highly regulated environment</li><li>Strong verbal and written communication skills</li><li>Team-oriented mindset with a collaborative approach</li><li>Comfortable working in cleanroom environments with PPE requirements</li></ul>

Role Description: <ul><li>This position will require an experienced, results-oriented professional to be responsible for Structural engineering.</li><li>The position will work in a multi-discipline team executing a variety of chemical manufacturing support projects and tasks to support our manufacturing sites.</li></ul> Responsibilities: <ul><li>Work with remote team members and global counterparts to develop deliverables required for structural fabrication and installation of projects and hence excellent communication skills a pre-requisite.</li><li>Provide structural analysis and engineering calculations of a variety of material types including but not limited to steel and concrete.</li><li>Provide structural analysis of steel and concrete elements.</li><li>Well versed with connection design calculations.</li><li>Participate in team model reviews.</li><li>Review Design Drawings</li></ul> Requirements: Basic Qualifications: <ul><li>Master’s degree in Structural Engineering from a reputed premiere institute.</li><li>Minimum 5 years of work experience in an Engineering and/or Engineering Services organization.</li><li>Must have engineering experience performing structural calculations and analysis of structures.</li><li>Computer Environment: Microsoft: Word, Excel, Power Point</li><li>Proficiency in STAAD Pro software</li><li>Should have exposure to environments of 2D and 3D CAD tools including Laser Scans, Bentley MicroStation, AVEVA and AutoCAD platforms or equivalent.</li><li>Experience with applicable industry codes including ACI, AISC, IBC and ability to utilize custom internal specifications as they apply to design and installation of structural assemblies and supports. Be able to perform tasks using U.S. or metric standards</li><li>Excellent written, listening, and verbal communication skills.</li></ul> Preferred Qualifications: <ul><li>Exposure to environments of 2D and 3D CAD tools including Laser Scans, Bentley MicroStation, AVEVA and AutoCAD platforms or equivalent.</li><li>Experience with applicable industry codes including ACI, AISC, IBC and ability to utilize custom internal specifications as they apply to design and installation of structural assemblies and supports. Be able to perform tasks using U.S. or metric standards.</li></ul>

Responsibilities: <ul><li>Provide daily quality oversight during manufacturing, warehousing, and qualification activities, including but not limited to line clearance and AQL sampling.</li><li>Ensure adherence to cGMP, SOPs, and regulatory standards.</li><li>Lead and execute QA review of batch records, logbooks, and related GMP documentation to support timely and accurate product disposition.</li><li>Develop, implement, and maintain site-specific quality procedures (SOPs, work instructions, forms) governing QA support responsibilities</li><li>Ensure proper execution of Good Documentation Practices (GDP)and data integrity in all manufacturing executed records.</li><li>Take active role in preparing the site for regulatory inspection.</li><li>Act as a QA representative during regulatory inspections, internal audits, and customer audits.</li><li>Contribute to the inspection readiness of the site, including periodic walkthroughs and risk-based quality improvements.</li></ul> Requirements: Qualifications / Experience <ul><li>Bachelor’s degree in a scientific or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering).</li><li>5+ years of experience in pharmaceutical manufacturing, or QA.</li><li>Familiarity with aseptic manufacturing, sterile injectable processes, and cleanroom environments.</li><li>Knowledge of FDA cGMPs, ICH Q8-Q10 guidelines, EU Annex 1, and risk-based qualification approaches.</li><li>Experience supporting regulatory inspections and validation documentation reviews.</li></ul> Skills / Competencies <ul><li>Strong knowledge of 21 CFR part 10, and 211.</li><li>Strong knowledge of aseptic GMP manufacturing and QA shopfloor support.</li><li>Excellent organizational and communication skills with high attention to detail.</li><li>Ability to work collaboratively with operations, and engineering.</li><li>Commitment to data integrity, continuous improvement, and patient safety.</li></ul>

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16 custom clearance Jobs found

Inspection Technician

Assistant Manager, HRBP

Logistics Supervisor

Logistics Analyst

IAD / SAD / LAD GCP Data Engineer

Customer Service Specialist- Malaysia

Supply Chain Analyst II

Production Technician I

Structural Engineer

Quality Associate I

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16 custom clearance Jobs found

Inspection Technician

Assistant Manager, HRBP

Logistics Supervisor

Logistics Analyst

IAD / SAD / LAD GCP Data Engineer

Customer Service Specialist- Malaysia

Supply Chain Analyst II

Production Technician I

Structural Engineer

Quality Associate I

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