Manager - 1 - Analytical Quality Assurance

The AQA Manager will be responsible for managing analytical QA activities in an OSD manufacturing plant, ensuring compliance with cGMP, regulatory requirements, and internal quality standards. The role involves oversight of laboratory practices, data integrity, review of analytical documents, and coordination with QC and other departments for timely product release and regulatory readiness.

Key Responsibilities:

• Ensure compliance with cGMP, regulatory guidelines (USFDA, MHRA, EU, etc.), and company SOPs in analytical QA activities.
• Review and approve analytical documents such as COAs, raw data, instrument logs, and calibration records.
• Oversee review and trending of stability data and OOS/OOT investigations.
• Manage audit preparedness for regulatory inspections and customer audits, with a focus on laboratory systems.
• Coordinate with QC and production teams for timely release of RM, PM, intermediates, and finished products.
• Ensure data integrity practices in the laboratory and conduct periodic internal audits.
• Support qualification and validation of analytical instruments and methods.
• Monitor and review environmental monitoring and microbiological data related to laboratory operations (if applicable).
• Lead AQA team and ensure continual training and development of team members.

Key Skills & Competencies:

• Strong knowledge of analytical techniques (HPLC, GC, UV, etc.) and regulatory expectations.
• Excellent understanding of laboratory quality systems and data integrity requirements.
• Good leadership, communication, and documentation skills.
• Analytical thinking and problem-solving ability.
• Proficiency in reviewing and interpreting analytical data.

Qualifications:

• M.Sc. / M.Pharm. in Analytical Chemistry / Pharmaceutical Sciences or related field.
• 8-12 years of experience in Analytical Quality Assurance in a regulated OSD manufacturing environment.
• Experience in handling regulatory audits (e.g., USFDA, MHRA, WHO, etc.) is essential.