Senior QA Engineer

Job Description: Senior QA Engineer (Pharma – API)

Location: Badlapur, Thane
Experience: 4–5 Years
Industry: Pharmaceuticals (API manufacturing experience is mandatory)
Department: Quality Assurance

Position Summary

The Senior QA Engineer will be responsible for ensuring compliance with QMS, GMP, GLP, and regulatory standards in an API manufacturing environment. This role involves documentation control, audits, deviation handling, change control, and coordination with cross-functional teams to ensure quality compliance across the plant.

Key ResponsibilitiesQuality Management System (QMS)

• Review and maintain QMS documentation in accordance with regulatory and organizational requirements.
• Ensure implementation and continual improvement of QMS across departments.
• Coordinate with various department heads to keep quality records updated and accurate.

Documentation Control

• Review and approval of SOPs for different functions within the plant.
• Review and support preparation of Master Formula Records (MFR), Batch Manufacturing Records (BMR), and other GMP documentation.
• Assist in preparing Annual Product Quality Reviews (APQR).

GMP & GLP Compliance

• Ensure adherence to GMP and GLP standards throughout manufacturing and laboratory operations.
• Conduct in-house GMP and GLP training sessions for staff.

Deviation, OOS, and Change Control Management

• Handle deviations, out-of-specification (OOS) issues, change controls, and their closure within defined timelines.
• Perform impact assessments and root cause analysis (RCA) in coordination with relevant teams.
• Ensure timely implementation, tracking, and documentation of corrective & preventive actions (CAPA).

Audits & Regulatory Compliance

• Support internal, external, customer, and regulatory audits.
• Assist in audit documentation, compliance verification, and follow-up of audit observations until closure.
• Participate in vendor qualification activities and vendor audits.

Product Release & Quality Coordination

• Coordinate with QC for product release and ensure that specifications and documentation meet quality requirements.
• Monitor risk management activities in accordance with regulatory expectations.

Customer Complaints

• Handle customer complaints, perform investigation, and ensure timely closure through CAPA implementation.

Additional Responsibilities

• Support in process validation activities and coordinate with manufacturing and quality teams.
• Assist in DMF (Drug Master File) related documentation (preferred).
• Ensure compliance with data integrity and company quality policies.

Candidate Requirements

• Education: B.Sc / M.Sc / B.Pharm / M.Pharm in Chemistry or related discipline.
• Experience: 4–5 years of QA experience in a pharma API manufacturing environment (mandatory).
• Strong knowledge of QMS, GMP, GLP, and regulatory guidelines (FDA/ISO/ICH).
• Experience in deviation handling, CAPA, OOS, change control, APQR, and SOP documentation.
• Experience in supporting internal/external audits and regulatory inspections.
• Good understanding of process validation and risk management tools.
• Strong communication, documentation, and coordination skills.

Job Types: Full-time, Permanent

Pay: ₹350,000.00 - ₹500,000.00 per year

Application Question(s):

• Are you currently working in Pharma Industry?

Education:

• Bachelor's (Preferred)

Experience:

• QA Engineer: 5 years (Required)

Location:

• Mumbai, Maharashtra (Required)

Work Location: In person