Assistant Manager Quality Assurance

To assist in the development, implementation, and maintenance of the Quality Management System (QMS) in compliance with local (DRAP) and international regulatory standards (cGMP, WHO, FDA, EMA). The role ensures that products are manufactured and released with the highest quality, safety, and efficacy standards.

• Ensure compliance with cGMP, DRAP, WHO, and ICH guidelines across all manufacturing and packaging activities.
• Supervise batch manufacturing record (BMR/BPR) review and approve documents for product release.
• Monitor in-process checks and ensure adherence to quality standards.
• Participate in internal audits, regulatory inspections, and customer audits, ensuring readiness and compliance.
• Coordinate deviation handling, CAPA (Corrective and Preventive Actions), OOS/OOT investigations, and change control.
• Oversee validation and qualification activities (process, cleaning, equipment, and utilities).
• Conduct training sessions for production and QA staff on quality systems and regulatory requirements.
• Review and approve SOPs, quality documents, and specifications.
• Support product quality review (PQR) and annual reports.
• Assist in continuous improvement initiatives to enhance product quality and reduce compliance risks.

Job Type: Full-time

Pay: Rs65,000.00 - Rs75,000.00 per month

Application Question(s):

• Only candidates with at least 4 to 5 years of Quality Assurance experience in pharmaceuticals are eligible to apply.

Experience:

• Pharmaceuticals Quality Assurance: 5 years (Required)

Work Location: In person