Executive - QC

About Sun Pharma and the Role

Located in Halol, Gujarat, Sun Pharma invites you to join its Global Operations business unit as an Executive or Senior Executive in Quality Control. The company fosters a culture of continuous personal and professional growth, encouraging employees to take initiative, collaborate actively, and thrive within a supportive community focused on excellence and compliance.

Primary Responsibilities

• Evaluate and approve Quality Management System (QMS) documentation such as OOS (Out of Specification), OOT (Out of Trend), laboratory events, deviations, change controls, and CAPA (Corrective and Preventive Actions).
• Review and authorize routine analytical raw data pertaining to finished products, APIs, in-process materials, packing materials, etc.
• Ensure the site remains consistently prepared for both regulatory inspections and internal audits, implementing corrective measures to address any findings responsibly.
• Maintain strict compliance with regulatory requirements related to product quality, manufacturing processes, and release procedures to guarantee the release of safe and effective pharmaceutical products in accordance with cGMP standards.
• Facilitate audits by internal teams and regulatory bodies, ensuring comprehensive understanding and resolution of audit observations across the site.
• Monitor current industry trends and internal challenges to identify opportunities for enhancing site quality assurance management and processes.
• Adhere rigorously to corporate values of pride, accountability, integrity, and diligence, ensuring all activities comply with regulatory, compliance, and safety standards.
• Conduct daily quality control system monitoring and maintenance rounds to ensure adherence.
• Participate actively in root cause analysis (RCA) and CAPA implementation as part of a team.
• Review and approve QA and QC related SOPs within EDMS software.
• Verify that QC responses adequately address observations raised during audits and quality checks.
• Approve investigation reports related to OOS, OOT, calibration issues, lab events, deviations, CAPA, and related action items.
• Authorize analytical certificates of analysis (CoA) and test plans using LIMS software.
• Review audit trails of laboratory instruments and software systems such as EWS, Empower, LabX, etc.
• Approve the release of raw materials and packaging materials in SAP HANA, and oversee analytical technology transfer, validation, and development activities.
• Provide comprehensive analytical data concerning OOS, OOT, lab events, FAR, OOC, CAPA, and recall cases for Quality Council and R&D teams as necessary.
• Contribute data for the annual quality review process.
• Verify qualification and training documentation for laboratory analysts to ensure compliance.
• Analyze trends arising from QA observations based on raw data review and suggest improvements.
• Approve protocols and reports related to stability, method transfers, method validations, and conduct pharmacopeia evaluation and equivalence assessments.
• Perform trend analysis on deviations and quality observations to evaluate the effectiveness of CAPA and address recurring issues.
• Engage actively in cross-functional investigations and respond appropriately to regulatory queries.
• Deliver technical training relevant to laboratory functions.
• Issue templates, documentation, logbooks, and maintain GMP documents for the QC laboratory.
• Verify data related to qualification of laboratory instruments and sample destruction.
• Conduct internal audits to ensure ongoing compliance.
• Review and approve raw material and stability summary reports.
• Lead site presentations and discussions on remediation of open action items, especially regarding computerized systems during global review meetings.

Educational and Experience Requirements

• Minimum qualification: M. Pharmacy, B. Pharma, or M.Sc. in Chemistry.
• Experience required: Over 10 years in quality control or related pharmaceutical quality assurance roles.

Additional Information

This position is graded as G12A within Sun Pharma's hierarchy and is based onsite at Halol. The role supports corporate values emphasizing accountability and regulatory compliance. Travel estimates for this role were not specified.

Disclaimer: The job description illustrates the general duties and qualifications expected but may be updated to reflect operational needs. The employer reserves the right to modify responsibilities and assign duties appropriate to the employee's expertise.

Your Growth at Sun Pharma

Sun Pharma provides a robust environment for your success and well-being, offering ample benefits and development opportunities to encourage continuous improvement and impactful contributions within the pharmaceutical industry.