Sr. Manager - Quality Assurance

Job Title:

Senior Manager- QA

Business Unit:

Global Quality & Compliance

Job Grade

G9 A/B

Location :

Paonta Sahib

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

Key responsibilities:

• Ensure batch production records are executed and reviewed per SOPs and cGMP regulations.
• QA review for “Right First Time” (>98%) of executed batch production records for batch release.
• Monitor completion of deviations and investigations related to product release.
• Conduct/approve investigations for market complaints, OOS/OOT, unplanned deviations, and ensure timely closure.
• Run electronic system reports to confirm batch release requirements.
• Collaborate with Planning, QC, PTT, MSTG, Stability, Engineering, Validation, and Regulatory Affairs for timely batch release.
• Conduct/review self-audits as per schedule with Manufacturing and Engineering.
• Identify continuous improvement opportunities for compliance and efficiency.
• Review and approve/reject master batch production records and SOPs.
• Review and approve/reject protocols/reports for exhibit batches, scale-up, process validation, cleaning validation, equipment qualification, calibration, etc.
• Provide training and development to staff.
• Approve master documents (Formulation orders, Manufacturing instructions, Packaging orders, specifications).
• Issue certificates of compliance per technical agreements.
• Ensure timely sampling of drug products, intermediates, stability samples.
• Support in-process activities and Annual Product Review (APR).
• Conduct Reviewer Certification program for master documents and batch records.
• Ensure Continuous Process Verification (CPV) program and trend in-process data.
• Review open CAPA and ensure effectiveness.
• Organize sample shipments to EU labs.
• Approve license certificates and IPQA SOPs.
• Manage IPQA lab instruments and CAPEX budgeting.
• Monitor sample management and batch release status.
• Review and approve APRs (PQR) and propose CAPAs.

Travel Estimate

Job Requirements

Educational Qualification

B. Pharma/ M. Pharma/ M.Sc.

Experience

Tenure: 16-20 Yrs.

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!

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