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

The Assistant / Deputy Manager - QC will oversee the Quality Control operations at the plant, ensuring compliance with cGMP, regulatory guidelines, and internal quality standards. The role requires strong leadership to manage the laboratory team, maintain robust analytical practices, and support timely release of products.

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.