Asst. Manager - QA

Job Description:

Position:          Asst. Manager - QA

Location:         Ahmedabad

Experience:     10- 12 Years

Industries:      Pharma-Formulation

Responsibilities:

• Laboratory Quality Assurance: Oversee quality assurance operations in the lab, ensuring that all pharmaceutical formulation tests, including raw material analysis, in-process testing, and finished product testing, are performed according to established quality standards.

• Regulatory Compliance: Ensure the lab operates in compliance with regulatory requirements such as GMP (Good Manufacturing Practices), GLP (Good Laboratory Practices), ISO standards, and other applicable pharmaceutical regulations. Prepare for and support inspections from regulatory bodies (e.g., FDA, EMA, WHO).
• Method Validation and Development: Collaborate with the R&D and lab teams to develop, validate, and optimize analytical methods for the analysis of pharmaceutical formulations, ensuring that the methods meet quality and regulatory standards.
• Product Testing & Documentation: Supervise the testing of pharmaceutical formulations, including stability studies, dissolution testing, and other relevant testing parameters. Ensure proper documentation of test results, deviations, and investigations.
• Investigation & Root Cause Analysis: Lead investigations into product non-conformities, deviations, or failures, performing root cause analysis and implementing Corrective and Preventive Actions (CAPA) in collaboration with the quality control and production teams.
• Laboratory Equipment & Calibration: Ensure that laboratory instruments and equipment are maintained, calibrated, and qualified as per GMP and regulatory requirements. Oversee equipment performance and troubleshoot any issues that arise.
• Quality Audits & Inspections: Assist in conducting internal audits of the laboratory and other departments to assess compliance with GMP and other regulatory standards. Support external regulatory inspections and audits, providing necessary documentation and addressing audit findings.
• Training & Development: Provide training and mentorship to laboratory personnel on QA protocols, regulatory requirements, and best practices in pharmaceutical formulation testing.
• Continuous Improvement: Identify opportunities for improving laboratory processes, test methods, and overall quality assurance practices. Implement process improvements to enhance efficiency, reduce errors, and maintain high standards.
• Cross-functional Collaboration: Work closely with the production, regulatory, and R&D teams to ensure that quality standards are maintained throughout the pharmaceutical formulation development and manufacturing processes.

Required Skills 

• Good Communication Skills
• Team Handling
• Logical

Required Qualification: - B.Pharm/M.Pharm 

Salary: - Upto 9.30 LPA

If you are interested for this opening please send updated resume on same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-