QE Specialist

Production Supervisor

Manager II – Quality & Reliability Engineering

Finance Manager

Senior Application Developer - MS Power Apps

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>

Responsibilities: <ul><li>Supervise daily manufacturing operations including formulation, filling, and packaging of sterile injectable IV bag products within cleanroom environments utilizing isolator technology.</li><li>Manage and develop production team members, providing coaching, training, and performance feedback to ensure adherence to standard operating procedures (SOPs) and quality expectations.</li><li>Author, review, and approve SOPs, batch records, and other production documentation to ensure compliance with cGMP and regulatory requirements.</li><li>Ensure compliance with cGMP, FDA, DEA, OSHA, and other regulatory requirements, particularly in handling high potent APIs and controlled substances.</li><li>Coordinate production schedules to meet demand and support planning, warehouse, and materials management functions.</li><li>Monitor key performance indicators (KPIs) for productivity, quality, and safety; implement corrective and preventive actions as needed.</li><li>Oversee line clearance, equipment setup, and cleaning activities, ensuring readiness for manufacturing operations and minimizing downtime.</li><li>Support deviations, investigations, and CAPA implementation in partnership with Quality Assurance and other support functions.</li><li>Drive continuous improvement initiatives to enhance operational efficiency, product quality, and operator engagement.</li><li>Ensure effective communication between production shifts and other departments to maintain smooth and efficient operations.</li><li>Maintain a strong safety culture, ensuring compliance with Environmental Health &amp; Safety (EHS) programs and best practices.</li></ul> Requirements: Qualifications/Experience: <ul><li>Bachelor’s degree in engineering, Life Sciences, or a related technical field preferred; equivalent experience considered.</li><li>Minimum of 3–5 years’ experience in pharmaceutical or biotechnology manufacturing, preferably in sterile or aseptic operations.</li><li>Supervisory experience leading production teams in a regulated environment.</li><li>Knowledge of cGMP, aseptic processing, and isolator-based manufacturing.</li><li>Experience with high potent APIs and/or controlled substances preferred.</li><li>Proficiency with production documentation, batch records, SOP authoring, and deviation processes.</li></ul> Requirements: Skills / Competencies: <ul><li>Strong leadership and team management skills with a focus on employee development.</li><li>Excellent organizational and problem-solving abilities.</li><li>Ability to manage multiple priorities in a fast-paced, dynamic environment.</li><li>Clear, concise communication skills (written and verbal).</li><li>Proficiency in Microsoft Office and familiarity with manufacturing execution systems (MES) or ERP platforms.</li><li>Commitment to data integrity, safety, and continuous improvement.</li></ul>

Responsibilities: <ul><li>Lead development and execution of standardized DfRE and RV methodologies across Converged Products.</li><li>Champion a Design for Six Sigma (DFSS) culture, mentoring and training product design teams.</li><li>Oversee product validation, including HALT/HAST testing, Test-to-Failure (TTF) methodologies, and DOE approaches.</li><li>Collaborate with Product Development Engineering (PDE), Manufacturing Process Development Engineering (MPDE), Field Application Engineering (FAE), and Advanced Quality Engineering (AQE) teams to integrate reliability considerations throughout the product lifecycle.</li><li>Develop comprehensive test and validation plans aligned with our client LeanPD stage-gate approach.</li><li>Drive early concept testing, failure mode identification, and iterative product design improvements.</li><li>Support failure analysis (F/A), Root Cause and Corrective Action (RCCA), and competitive benchmarking activities.</li><li>Partner with Global R&amp;T COE to develop custom test equipment, test systems, and software for unique testing requirements.</li><li>Manage and coach a high-performing team, ensuring clear accountability, skill development, and work-life balance.</li></ul> Requirements: <ul><li>Bachelor’s or Master’s degree in Electrical Engineering, Electronics, or Mechatronics.</li><li>10+ years of experience in all aspects of reliability engineering for electronic or mechatronic products (reliability estimation, calculation, and risk identification).</li><li>Extensive experience with test equipment, test systems, labs, HALT/HAST testing, validation plans, and custom test systems.</li><li>Proven experience working with global, cross-functional engineering teams in multi-site organizations.</li><li>Strong analytical, critical thinking, and problem-solving skills.</li><li>Knowledge of FIT estimation methodology, Weibull/Chi-Square statistical analysis, FMEDA, FTA, and Bayes theorem applications.</li><li>Reliability engineering training from ASQ, TUV, Reliasoft, or equivalent.</li><li>Excellent written and verbal communication skills in English.</li><li>Willingness to travel up to ~20%.</li></ul>

Responsibilities: Financial Leadership and Management:&nbsp; <ul><li>Oversee all aspects of the finance departments operations, including accounting, budgeting, forecasting, financial reporting, and taxation.</li><li>Develop and implement robust financial policies, procedures, and controls to safeguard company assets and ensure accuracy of financial information.</li><li>Prepare and present timely and accurate financial statements and reports to management, providing insightful analysis and recommendations.</li><li>Manage cash flow effectively, optimizing working capital and ensuring sufficient liquidity.</li><li>Lead and mentor the finance team, fostering a collaborative and high-performing environment.</li><li>Liaise with auditors, tax consultants, and other external stakeholders.</li></ul> Import and Export Transaction Management:&nbsp; <ul><li>Oversee and manage all import and export transactions, ensuring adherence to company policies and regulatory requirements.</li><li>Handle the issuance, negotiation, and settlement of various trade finance instruments, including Letters of Credit (LCs), Standby LCs, and Bank Guarantees.</li><li>Develop and maintain strong relationships with banks and financial institutions for trade finance facilities.</li><li>Ensure meticulous documentation related to import and export activities, including invoices, packing lists, bills of lading, and customs declarations.</li><li>Track and reconcile all payments related to import and export transactions.</li></ul> Compliance and Regulatory Adherence:&nbsp; <ul><li>Ensure strict compliance with all applicable international trade regulations, including INCOTERMS, Uniform Customs and Practice for Documentary Credits (UCP 600), Foreign Exchange Management Act (FEMA) and Reserve Bank of India (RBI) guidelines.</li><li>Stay updated on changes in trade regulations and implement necessary adjustments to processes.</li><li>Manage all aspects of customs clearance and ensure timely submission of required documentation.</li></ul> Logistics and Stakeholder Coordination:&nbsp; <ul><li>Liaise effectively with freight forwarders, customs brokers, and internal logistics teams to ensure smooth and efficient documentation and payment processing for import and export shipments.</li><li>Address and resolve any discrepancies or issues related to trade finance and logistics.</li><li>Maintain clear and proactive communication with suppliers, customers, and other relevant stakeholders regarding financial aspects of international trade.</li></ul> Strategic Financial Planning:&nbsp; <ul><li>Contribute to the development and execution of the companys overall financial strategy.</li><li>Provide financial insights and support for international business development initiatives.</li><li>Analyze the financial implications of import and export activities and recommend strategies to optimize costs and mitigate risks.</li></ul> Requirements: <ul><li>Qualified Company Secretary (CS) is mandatory.</li><li>Bachelors degree in Finance, Accounting, or a related field; a Masters degree or relevant professional certifications (e.g.,1 CA, CPA, CFA) would be an advantage.</li><li>Minimum of 10 years of progressive experience in finance, with a significant portion focused on managing import and export trade finance.</li><li>In-depth knowledge and practical experience in handling Letters of Credit, Standby LCs, and Bank Guarantees.</li><li>Thorough understanding of international trade regulations (INCOTERMS, UCP 600, FEMA/RBI guidelines) and customs procedures.</li><li>Proven ability to manage the entire finance function, including accounting, budgeting, financial reporting, and compliance.</li><li>Strong analytical and problem-solving skills with meticulous attention to detail.</li><li>Excellent communication, interpersonal, and negotiation skills.</li><li>Proficiency in relevant accounting software and MS Office Suite (especially Excel).</li><li>Ability to work independently and as part of a team in a fast-paced environment.</li></ul>

Responsibilities: <ul><li>Lead the design and development of complex Power Apps solutions (both canvas and model-driven) to meet advanced business requirements.</li><li>Architect and implement sophisticated Power Automate workflows (including child flows and RPA) that integrate with various systems and APIs.</li><li>Develop custom business logic and integrations (using advanced Power Fx, Azure Functions, custom connectors, etc.) to extend Power Platform capabilities.</li><li>Configure and optimize Microsoft Dataverse schemas, Azure SQL Tables. Manage data flows between Power Apps and external databases or ERP/CRM systems.</li><li>Ensure solutions are secure, scalable, and compliant with best practices (including governance, authentication, and data validation) .</li><li>Troubleshoot and resolve production issues and performance bottlenecks in Power Platform applications</li><li>Mentor junior developers and work closely with cross-functional teams (business analysts, IT, etc.) to support the full application lifecycle and drive continuous improvement.</li></ul> Requirements: <ul><li>Bachelor’s degree in computer science, Engineering, or a related technical field and 6 - 9 years of hands-on Power Platform development experience</li><li>Expert proficiency in Power Apps development (Canvas and Model-driven) including advanced Power Fx, component framework (PCF), and ALM practices</li><li>Extensive experience with Power Automate (cloud flows, UI flows) and proven ability to integrate Power Platform with other systems and services</li><li>Strong programming skills (JavaScript/TypeScript, C#, .NET, HTML) and experience with RESTful APIs and Azure development tools (Visual Studio, VS Code)</li><li>Experience with data modeling and database design (Microsoft Dataverse, SQL Server, Azure SQL)</li><li>Solid understanding of security and authentication (Azure AD) in the Power Platform context</li><li>Excellent problem-solving skills and the ability to translate business needs into technical solutions</li><li>Strong communication and collaboration skills for engaging with stakeholders and mentoring team members</li></ul>

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QE Specialist

Production Supervisor

Manager II – Quality & Reliability Engineering

Finance Manager

Senior Application Developer - MS Power Apps

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QE Specialist

Production Supervisor

Manager II – Quality & Reliability Engineering

Finance Manager

Senior Application Developer - MS Power Apps

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