Quality Assurance Specialist / Assistant Manager

Investigation & Reporting:

✅ CAPA Management:

• Review, track, and ensure timely implementation of CAPA actions with zero overdue CAPAs.
• Perform CAPA effectiveness checks as per established timelines.

✅ Product Complaint Handling:

• Ensure on-time response and closure of product complaints.
• Prepare and submit MIS data for product complaints by the 2nd working day of each month.
• Analyze trends in product complaints and recommend improvements to enhance product and process quality.

✅ Continued Process Verification (CPV):

• Prepare CPV reports in compliance with regulatory requirements after 30 batches of a generic product.
• Compile and analyze manufacturing, laboratory testing, and associated data for CPV.
• Identify and resolve issues during CPV report compilation efficiently.

✅ Quality & Compliance Monitoring:

• Establish and maintain OOT monitoring limits for effective quality control.
• Ensure compliance with GMP, regulatory guidelines, and company SOPs.

🔹 Required Skills & Qualifications:

🎯 Education: [B.Pharm / M.Pharm / MSc in Pharmaceutical Science / Chemistry or related field]
🎯 Experience: 7 to 8 years in pharmaceutical quality assurance, investigations, and CAPA management.
🎯 Technical Expertise:

• Regulatory Compliance GMP, FDA, ICH guidelines.
• Investigation & Root Cause Analysis – Handling OOS, OOT, and deviations.
• CPV & Statistical Evaluation – Experience with Minitab for trend analysis.
• Documentation & Reporting – Strong skills in report writing, SOP preparation, and data analysis.
• Software Proficiency – Expertise in MS Office (Excel, PowerPoint, Word).

🔹 Soft Skills & Personal Development Areas:

✔ Strong communication and email writing skills for effective client interactions.
✔ Ability to identify trends, analyze data, and implement improvements proactively.
✔ Excellent problem-solving and decision-making skills.
✔ Ability to meet deadlines and work in a fast-paced environment.
✔ Willingness to complete LMS courses within defined timelines for continuous learning.