Assistant Manager- Stability Testing/Analytical Method Development/Process Validation

Key Responsibilities

• Supervise and manage daily Quality Control activities for raw materials, packaging materials, intermediates, and finished products.
• Ensure adherence to GLP, cGMP, and regulatory requirements (e.g., USFDA, WHO-GMP, EU, etc.).
• Review and approve analytical data, specifications, and COAs.
• Oversee method validation, method transfer, and stability studies as per protocols.
• Investigate out-of-specification (OOS) and out-of-trend (OOT) results and implement corrective and preventive actions (CAPA).
• Coordinate with cross-functional teams for timely release of materials and products.
• Ensure proper calibration and maintenance of QC instruments like HPLC, GC, UV, IR, Dissolution testers, etc.
• Maintain and review QC documentation such as SOPs, protocols, logbooks, and test records.
• Support internal and external audits; ensure audit readiness at all times.
• Provide training and development to QC team members.
• Implement continuous improvement initiatives within the QC laboratory.

Qualifications and Experience

• B.Pharm / M.Pharm / M.Sc. in Chemistry or related field.
• 8–12 years of experience in Quality Control in the pharmaceutical industry.
• Strong knowledge of analytical techniques and instruments.
• Experience in regulated markets and regulatory audits (preferred).
• Familiar with data integrity and documentation compliance.
• Proficiency in software like LIMS, Empower, or equivalent (advantageous).

Skills Required

• Excellent analytical and problem-solving skills.
• Leadership and team management.
• Strong documentation and review capability.
• Good communication and coordination skills.
• Attention to detail and regulatory mindset.