Compounding Technician

Filling Technician

Senior - Data Engineer

Continuous Improvement Analyst II

Lead, Card Operations Processing Centre

Quality Improvement Manager

Senior Quality & Reliability Engineer

Finance Business Partner

QC Lab Sample Coordinator

QE Specialist

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process 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 Production Technician I 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>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</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 compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</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>Demonstrated problem-solving and mechanical 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>At home working in cleanroom environments with PPE requirements.</li></ul>

Responsibilities: <ul><li>Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.</li><li>Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.</li><li>Serve as first-line troubleshooting support for equipment and process 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 Production Technician I 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>Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.</li><li>Ensure controlled substances are handled, documented, and stored per DEA and site requirements.</li><li>Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.</li></ul> Requirements: Qualifications / Experience&nbsp; <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 compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.</li><li>Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.</li><li>Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.</li><li>Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.</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>Demonstrated problem-solving and mechanical 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>At home working in cleanroom environments with PPE requirements.</li></ul>

Responsibilities: <ul><li>Uses a set of tasks and techniques to work as a liaison among and elicit the needs of stakeholders to define and validate solutions that meet business needs, goals, or objectives.</li><li>Analyzes and synthesize information elicited from stakeholders, defines, and manages the plan to deliver requirements and documents, and manages requirements throughout the project life cycle.</li><li>Develop ETL (Extract, transform, load) process to help extract and manipulate data from multiple sources.</li><li>Reformulating or automating the existing data workflows to maximize their functioning and greater scalability.</li><li>Critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, and produce actionable business insights out of it.</li><li>Need to conduct complex data analysis and improve data quality and efficiency.</li><li>Develop models to create reporting infrastructure/dashboards for business process management and data mining.</li><li>Design Summary, Detail, and Dashboard reports and management summaries which present data findings in a professional, concise, and readable format appropriate for content and audience.</li><li>Solve ad-hoc requirements of Management related to data for critical decision making</li><li>Troubleshoot data inaccuracies, identify root causes, and take corrective action</li><li>Effectively communicate and translate quantity findings (Storytelling with data) inclusive of key insights and actionable recommendations to optimize performance</li><li>Optimize reports to ensure a responsive solution when visualizing vast amounts of data.</li></ul> Requirements: <ul><li>5+ years of data engineering experience in ETL design, development, optimization &amp; testing using, Alteryx, Data Bricks, Cloud AWS Services, Python, SQL scripts,</li><li>5+ years of hands-on experience in business intelligence and in configuring, designing, and building visualizations and dashboards using Tableau and other BI tools (Tableau Prep, Tableau Dashboard, Tableau Server, Business Objects, Power BI, etc.)</li><li>Excellent problem-solving, communication, and organizational skills.&nbsp;</li><li>Experience in performance tuning and optimization of ETL processes to enhance efficiency and minimize data processing time</li><li>Detail-oriented with excellent time management and organizational skills to meet a critical deadline</li><li>Self-motivated, ability to prioritize work and multi-task across many assignments in a fast-paced work environment</li><li>Collaborated with cross-functional teams to gather requirements, design data models, and implement scalable data architectures to support business analytics and reporting needs</li><li>Proven ability to work independently and with a team.</li><li>Ability to interpret technical or dashboard structure</li><li>Experience in business domains – supply chain, pricing, sales &amp; marketing, sales, finances</li></ul>

Overview:﻿ <ul><li>Working with the Lean implementation team to integrate Lean tools into operations as well as drive performance improvement.&nbsp;</li><li>Act as the local subject matter expert for the Lean tools and be responsible for all Lean activities at the local site.&nbsp;</li><li>Develop and conduct the Lean star level plan by driving and monitoring the projects of operation advantage, providing necessary technical support and facilitating cross-functional team to meet the metrics as planned.&nbsp;</li></ul> Responsibilities: <ul><li>Overall manage plant annual lean plan, identifying key improvement priorities to enhance site performance in the eyes of all stakeholders.</li><li>To implement system in plant and achieve Star level plant through improvement activity.</li><li>Conduct site level workshops and VSM transformation projects with focus on achieving operational excellence.&nbsp;</li><li>Systematic to manager plant cost activity, identify/improve/control the efficiency, material, labor and be all aspect of the cost viewing. </li><li>Being responsible fofr driving conversion productivity.&nbsp;</li><li>Key member of global lean committee, share/provide/lead global projects and activities.</li><li>Take role as internal process/cost consultants, to assistant plant manager solve management issues</li><li>Provide leadership on lean thinking, lean processing and lean production, continue to promote the culture of continuous improvement.</li><li>Lead / lean know-how transfer projects, to implement, optimize and solve specific problems in operation&nbsp;</li></ul> Requirements: <ul><li>B.S. Degree in engineering or technical field.</li><li>Minimum 8 years working experiences, 3 years working experiences as Continuous Improvement at least.&nbsp;</li><li>Professional experience with focus on production, logistics or industrial engineering is an advantage.</li><li>Previous experience in leading both of continuous improvement activities and value stream transformation projects.</li><li>Good flexibility and can work under pressure</li><li>Demonstrate the ability to lead change, a great team-work player.</li><li>Excellent communication and coaching skills, strong leadership skills.</li><li>Ability to think strategically and execute tactically, being result-oriented.</li><li>Project management skills.</li><li>Fluent in both spoken and written English and local language is essential.</li><li class="ql-align-justify">Lean Six Sigma Black Belt Certification is an advantage</li></ul>

Responsibilities: <ul><li>Streamline processes to reduce operating cost and turnaround time without compromising quality and risk.&nbsp;</li><li>Conduct internal reviews / tests to ensure compliance.</li><li>Assist with data analysis, report findings, recommend corrective actions and preventive actions for review.&nbsp;&nbsp;</li><li>Proactively manage and resolve customers’ and business units’ feedback and queries promptly.</li><li>Drive operations related projects &amp; process improvements.</li><li>Lead and coach staff to a high standard of performance, productivity and service quality</li><li>Ensure that the Bank’s policies, guidelines, operations control and compliance requirements are strictly adhered to.</li><li>Ensure that operation procedures are kept up to-date.</li><li>Identify opportunities to improve productivity, efficiency and service quality in the team and within the division while assuming the role as a mentor to coach staff to ensure high standard of performance, productivity and service quality.</li></ul> Requirements: <ul><li>5 to 10 years of retail banking operations, especially in Credit/Debit Cards Operations&nbsp;</li><li>5 to 10 years of team management experience with a minimum size of 10.</li><li>Able to multi-task and cope with change and diversity in a fast-paced environment</li><li>Experience in change management projects, including successful RPA and automation implementations.</li><li>Strong organizational and management skills with strong leadership qualities</li><li>Strong analytical and problem-solving skills</li><li>Strong interpersonal and communication skills with excellent verbal/written communication and interpersonal skills.</li><li>Ability to think objectively and think outside the box when analyzing issues</li><li>Ability to work under pressure.</li></ul>

Role Information: <ul><li>The Quality Improvement Manager is responsible to drive and support improvement activities and convergent Problem-Solving competencies within AUT ASEAN, leveraging scalable methodologies and digital tools while unleashing people’s talent.</li><li>Working in collaboration with production plant at Gateway Thailand towards waste reduction and improving Incidents on our customer base.&nbsp;</li><li>She/he is the Leader in ASEAN Problem Solving Committee and leads cross functional teams to solve complex and difficult manufacturing and quality problems.</li><li>She/he contributes to the project selection that will have the highest impact on plant metrics.</li><li>She/he coaches plant problem solvers and ensures their development</li></ul> Responsibilities: <ul><li>Leader in ASEAN Problem Solving (PS) Committee.</li><li>Organize regular meeting review status &amp; planning.</li><li>Promote PS culture throughout the Plant and ASEAN at all levels.</li><li>Promote the selection of the projects that will have the highest impact on plant metrics (eg. CoPQ) and manage all PS projects including PS initiatives from Line QRM escalation to VSM/Plant Level.</li><li>Support production improvement process through PS projects.</li><li>Lead cross-functional team to apply diligently a structured problem-solving methodology that best fits the situation (Shainin, SPS, Six Sigma or other equivalent methods as described by the Shifting Gears)</li><li>Follow up all PS projects with project owner and provide coaching to ensure PS methodologies are correctly applied.</li><li>Regular project coaching with PS Master from Global, and follow-up to project closure and realize saving.</li><li>Proactively anticipate roadblocks to find solutions and escalate when needed.</li><li>Report out project progress, people development and savings to PS Committee and Management.</li><li>Tabulate and manage Plant/ASEAN people PS skill matrix and identify training needs, plan &amp; execution.</li><li>Coach, Develop and Expand local Problem Solver Practitioners.</li><li>Represent ASEAN in PS matter and report status to regional and global level.</li><li>Alignment with AP and Global PS leaders for new PS initiatives and execution.</li><li>Any other assignments as delegated by reporting Manager.</li></ul> Requirements: <ul><li>Engineering degree (Mechanical or Electrical Engineering).</li><li>Strong understanding of 6 Sigma tools and Minitab usage.</li><li>Strong understanding of engineering fundamentals and product design</li><li>Experience in taking project using structured problem-solving methodology (Shainin Red-X, 6 Sigma, etc).</li><li>Experience in coaching and training.</li></ul> Specific Requirements(Mandatory): <ul><li>Certified Red X Master or Master Candidate (ability to coach) or Kepner-Tregoe.</li><li>Strong understanding of 6 Sigma tools and Minitab usage.</li><li>Able to develop Dashboard (PowerBI) and to apply Data Science (Python, R).</li></ul>

Responsibilities: Quality System &amp; Compliance <ul><li>Develop and implement quality and reliability processes to support NPI.</li><li>Lead the development and scaling of the site Quality Management System (QMS).</li><li>Ensure QMS elements (management reviews, internal audits, supplier management) comply with global standards.</li><li>Act as Lead Auditor for internal audits and ensure compliance with ISO 13485 and FDA QSR.</li><li>Support external audits, including preparation, mock audits, and corrective actions.</li><li>Review and approve ECOs, DCOs, training matrices, and other NPI documentation.</li><li>Maintain updated quality policies and procedures aligned with evolving standards.</li></ul> NPI Planning &amp; Execution <ul><li>Represent Quality in customer meetings and business reviews.</li><li>Collaborate with cross-functional teams including engineering, manufacturing, PMO, and supply chain.</li><li>Support implementation of electronic quality systems for improved traceability and documentation.</li><li>Evaluate product development objectives to identify quality improvement opportunities.</li><li>Create, review, and maintain quality system documents specific to NPI.</li><li>Calculate and present NPI quality KPIs.</li></ul> Continuous Improvement &amp; Problem Solving <ul><li>Lead or support quality system improvement projects.</li><li>Use statistical and scientific methods to analyze data and drive improvements.</li><li>Provide expertise in CAPA, root cause analysis, and reliability engineering tools.</li><li>Facilitate cross-functional improvement teams focused on NPI processes.</li></ul> Training &amp; Leadership <ul><li>Conduct training in GDP, GMP, CAPA, and compliance topics.</li><li>Oversee CAPA investigations to ensure true root cause identification and effective corrective actions.</li><li>Supervise and mentor Quality Engineers supporting NPI initiatives.</li></ul> Requirements: Required Skills &amp; Competencies Core Competencies <ul><li>Strong technical learning ability</li><li>Excellent problem-solving and analytical thinking</li><li>High ethical standards and integrity</li><li>Action-oriented and self-driven</li></ul> Job-Specific Skills <ul><li>Knowledge of NCMRs, CARs, CAPA, customer complaints, RMA metrics, DPPM, and DLPM</li><li>Strong technical "hands-on" skills</li><li>Excellent communication and interpersonal abilities</li><li>Ability to manage multiple tasks in a fast-paced environment</li><li>Strong prioritization and organizational skills</li><li>Proficiency in Microsoft Office (Word, Excel, PowerPoint, Visio)</li><li>Advanced technical report writing skills</li><li>Strong understanding of ISO 13485 and FDA QSR</li><li>Bilingual English (Advanced) / Spanish preferred</li><li>Willingness to travel up to 20% (based in Costa Rica)</li></ul> Experience &amp; Education <ul><li>Experience: 5+ years of Quality leadership experience in a manufacturing environment, preferably in multinational settings and NPI roles.</li><li>Education: Bachelor’s degree in a scientific or engineering discipline.</li><li>Certifications: CQE/CSSBB certification preferred.</li></ul>

Responsibilities: <ul><li>The Finance Business Partner, Operations will be providing timely, relevant and accurate information and insightful analysis to facilitate decision-making of senior management.</li><li>Developing the capability to drive swift data extraction and visualization bringing visibility and transparency of key business metrics.</li><li>Focused on finding meaningful insights to support continued and sustainable profitable growth of the our client business.</li><li>Drive improvement in the conversion cost and site fixed overhead vs budget and historical periods.</li><li>Also, bringing actionable insights, identity focus areas and run simulations for site management to optimize the cost level, in line with forecasted business activity.</li><li>Need monthly tracking and action monitoring, working collaboratively with site teams across different functions, and create visibility with global manufacturing team on the improvement actions.</li><li>Drive digital transformation journey of finance function and be instrumental in increasing utilization of BI tools, especially Power BI.</li><li>To include developing the dashboards and power query models required to achieve efficiency in data extraction and visualization.</li><li>Understand diverse internal and external data source and its architecture.</li><li>Able to integrate various data source for seamless automation of business analysis resulting in optimization of core financial workflows, enhancing efficiencies.</li><li>Able to perform analysis using large complex dataset, enhance the reports to improve performance tracking against targets and trend identification.</li><li>Effective contribution in annual budgeting and monthly forecasting process, such as developing templates for end-to-end budget planning and forecasting process.</li><li>Build and foster strong cross-functional relationships across business constituencies and stakeholders specially group support functions like Supply Chain, Manufacturing Ops and Procurement. Help the company understand how the pieces fit together to drive performance and strengthen the team’s partnership and influencing skills in pursuit of growth.</li><li>Price, Mix and Volume Analysis for Margin Improvements</li><li>Proactive participation in various business improvement/ad hoc projects.</li><li>Manages the overall Financial Reporting and Analysis activities in the production and delivery of all standard reporting (including template and chart updates), ad hoc reporting, presentation materials; and non-pricing / profitability (costing) analysis for the business, in accordance with defined standards.</li></ul> Requirements: <ul><li>At least 8-10 years’ work experience in Finance with at least 6 years’ experience in FP&amp;A</li><li>Experience working in manufacturing environment is a must</li><li>Strong business acumen.</li><li>Strong financial, technical, and quantitative analytical skills</li><li>In-depth knowledge of accounting principles, practices and regulatory issues and their application to a wide variety of areas</li><li>Ability to take ownership of a task or process, and see it through from inception to completion</li></ul> Preferred Skills <ul><li>Proven track record of developing and implementing value-added financial analysis</li><li>Self-awareness and ability to handle tight deadlines and manage complex business challenges</li><li>Demonstrated experience in analyzing and synthesizing complex financial data into meaningful executive summary statements</li><li>Excellent verbal and written skills, analytical thinker / problem solver, interpersonal skills, attention to details</li><li>Advance Excel skill, MS office and data management, Power BI skill is added advantage</li></ul> Key Relationships with Internal and External Stakeholders <ul><li>Operational Leadership</li><li>Site Finance Controllers</li><li>Group Finance Team</li><li>Site GMs and Operation team</li></ul> Additional Notes <ul><li>Sound financial knowledge with Chartered Accountant background</li></ul>

Responsibilities: Sample Management <ul><li>Performs QC sample/reference standard/chromatographic column receipt, processing, distribution for testing and storage.</li><li>Performs QC sample reconciliation and disposal.</li><li>Tracks inventory of product samples, stability samples, and test materials in the lab.</li><li>Uses laboratory software for sample, reference standard, chromatographic column management.</li><li>Verifies accuracy of labeling/documentation provided with samples.</li><li>Informs QC Coordinator if chemical or reference standard is expired for removal from laboratory area.</li><li>Send samples for outside testing. Submit samples to the appropriate labs for testing.</li><li>Create and maintain reports including quality data trending, informational spreadsheets, laboratory log spreadsheets.</li><li>Compile a list of necessary laboratory supplies specifically reference standards, contacting vendors to obtain quotes.</li><li>Uses the purchasing system to procure laboratory supplies.</li><li>Provide status updates to QC management and other departments regarding the submission of samples.</li><li>Maintain a safe work environment by following standards and procedures and complying with legal regulations.</li></ul> Lab Equipment <ul><li>Maintains, operates equipment and instruments supporting sample processing.</li><li>Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping.</li><li>Works with internal resources to maintain lab in an optimal state. Cleans lab working surfaces and disposes of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals.</li><li>Under close supervision, learns to troubleshoot basic instrument problems.</li></ul> Investigations&nbsp; <ul><li>Escalates any trends/events to the QC Lab Manager.</li><li>Escalates any sample and reference standard documentation issues to the QC Lab Manager.</li><li>With guidance, participates in OOS/OOT/NOE and other investigations.</li><li>Assists, as and when needed, scientists working in the laboratory.</li><li>May assist in drafting, editing, and reviewing SOPs.</li></ul> Training <ul><li>Maintains assigned training records current and in-compliance.</li><li>May assist in the training of laboratory staff.</li></ul> Compliance&nbsp; <ul><li>Performs assigned work in a timely and safe manner conforming to regulatory, company and compendia requirements within pharmaceutical manufacturing setting.</li><li>Documents accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs.</li><li>Follows internal processes related to controlled substances.</li></ul> Safety <ul><li>Follows EH&amp;S procedures to ensure a safe work environment.</li><li>Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS.</li></ul> Requirements: Education &amp; Experience <ul><li>College graduate, preferably in a Science related field.</li><li>Laboratory experience related to sample management preferred.</li></ul> Knowledge <ul><li>Basic knowledge of sample management in a laboratory environment.</li><li>Some knowledge of applicable safety and standards guidelines: SOP, cGMP, GLP, DEA regulations and/or MSDS.</li><li>Competency in Microsoft Office Suite.</li><li>Proficiency with computer savvy.</li></ul> Skills &amp; Abilities <ul><li>Ability to display and analyze data in a logical manner.</li><li>Good verbal and written communication skills as well as good computer skills.</li><li>Attention to details and accurate record keeping.</li><li>Establish and maintain cooperative working relationships with others.</li><li>Solid organizational skills</li><li>Ability to take initiative, set priorities and follow through on assignments.</li></ul> Physical Requirements <ul><li>Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel.</li><li>Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals.</li><li>Must occasionally lift and/or move up to 15-25 lbs.</li><li>Ability to wear personal protective equipment, including respirators, gloves, etc.</li><li>Specific visions abilities are required by this job include close vision and color vision</li><li>Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods.</li></ul>

Responsibilities: <ul><li>Provide real-time QA oversight on the production floor, in warehouse areas, and during qualification activities.</li><li>Perform batch record and logbook review, ensuring accuracy, completeness, and compliance with GDP standards.</li><li>Execute and document line clearance and room readiness inspections prior to manufacturing activities.</li><li>Review qualification and validation protocols for clarity, compliance, and alignment with regulatory and internal quality expectations.</li><li>Support execution of qualification protocols by providing on-site quality presence during testing and ensuring deviations are properly documented and escalated. 6.	Initiate, investigate, and support closure of deviations, non-conformances, and CAPAs related to manufacturing and qualification activities.</li><li>Collaborate with cross-functional teams to ensure timely and compliant execution of commissioning, qualification, and validation activities.</li><li>Support the development and maintenance of site-specific quality procedures (SOPs, work instructions, forms) governing manufacturing, warehousing, engineering, maintenance, and validation operations.</li><li>Review and approve site procedures to ensure clarity and compliance with cGMP standards.</li><li>Maintain awareness of site policies, cGMP regulations, and evolving regulatory expectations applicable to sterile injectable operations.</li><li>Participate in internal walkthroughs, audit preparations, and readiness activities for regulatory inspections.</li><li>Support the implementation of continuous improvement initiatives and site quality metrics.</li></ul> Requirements: Qualifications/Experience <ul><li>Bachelor’s degree in a scientific, engineering, or technical discipline (e.g., Biology, Chemistry, Pharmacy, Engineering)</li><li>2–5 years of experience in quality assurance, manufacturing, or validation in a cGMP-regulated pharmaceutical or biotech manufacturing environment</li><li>Working knowledge of FDA, EU, and ICH guidelines related to sterile manufacturing, validation, and data integrity</li><li>Experience supporting commissioning and qualification activities is strongly preferred</li><li>Familiarity with GDP, batch record review, and deviation documentation processes</li></ul> Skills/Competencies <ul><li>Strong attention to detail and commitment to compliance</li><li>Solid written and verbal communication skills</li><li>Ability to work collaboratively across departments in a fast-paced environment</li><li>Comfortable supporting shop-floor activities and cross-functional execution teams</li><li>Proficient in using quality systems and document management tools</li><li>Flexible and adaptable to changing priorities and evolving project timelines</li><li>Commitment to data integrity, continuous improvement, and patient safety</li></ul>

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176 signals data processing Jobs found

Compounding Technician

Filling Technician

Senior - Data Engineer

Continuous Improvement Analyst II

Lead, Card Operations Processing Centre

Quality Improvement Manager

Senior Quality & Reliability Engineer

Finance Business Partner

QC Lab Sample Coordinator

QE Specialist

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Skills

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Location

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176 signals data processing Jobs found

Compounding Technician

Filling Technician

Senior - Data Engineer

Continuous Improvement Analyst II

Lead, Card Operations Processing Centre

Quality Improvement Manager

Senior Quality & Reliability Engineer

Finance Business Partner

QC Lab Sample Coordinator

QE Specialist

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.