Greetings!!!!

Job Summary:

We are seeking an experienced Manager Analytical Quality Control (QC) to lead the Analytical QC function at a large-scale pharmaceutical manufacturing facility. The role is responsible for ensuring compliance with cGMP, GLP, USFDA, EU, and WHO regulatory requirements, while driving excellence in laboratory operations, data integrity, and quality compliance.

The incumbent will oversee end-to-end QC analytical activities including raw materials, packaging materials, in-process, finished products, and stability samples, along with strong focus on regulatory inspections, investigations, and team leadership.

Key Responsibilities:

Quality Control Operations

- Lead end-to-end Analytical QC laboratory operations
- Oversee testing of RM, PM, IP, FP, and stability samples
- Ensure timely release of analytical results with high accuracy

Compliance & Regulatory

- Ensure strict adherence to cGMP, GLP, and global regulatory guidelines
- Maintain data integrity compliance (ALCOA+)
- Support and lead regulatory audits (USFDA / EU / WHO / Internal audits)
- Ensure audit readiness at all times

Investigations & Quality Systems

- Handle OOS / OOT / Deviations
- Lead root cause analysis and implement effective CAPA
- Ensure closure of quality incidents within timelines

Instrumentation & Laboratory Management

- Oversee analytical instruments such as HPLC, GC, UV, Dissolution, etc.
- Ensure calibration, qualification,



and preventive maintenance of instruments
- Ensure laboratory compliance with SOPs and GLP practices

Team Leadership

- Lead and mentor QC analytical team
- Drive training, development, and capability building
- Allocate responsibilities and ensure performance management

Cross-functional Coordination

- Work closely with QA, Production, Regulatory Affairs, and R&D; teams
- Support validation activities and product lifecycle quality support

Key Skills Required:

- Strong expertise in Analytical Quality Control in pharma manufacturing
- Hands-on experience in HPLC, GC, UV, Dissolution techniques
- Strong knowledge of USFDA, EU GMP, WHO guidelines
- Expertise in OOS/OOT investigations and CAPA management
- Strong understanding of data integrity (ALCOA+)
- Leadership and team management experience
- Strong documentation and audit handling skills

Preferred Candidate Profile:

- Experience in regulated pharma manufacturing environment
- Exposure to global regulatory audits (USFDA/EU/WHO)
- Strong analytical thinking and problem-solving ability
- Experience handling large QC teams

Why Join Us:

- Opportunity to lead a critical QC function in a regulated manufacturing facility
- Exposure to global regulatory standards and audits
- Solid leadership role with end-to-end responsibility
- Growth-oriented and compliance-driven environment

Interested Candidates Kindly share your update cv to [email protected]

📌 Manager _ Analytical Quality Control (QC)_Pharmaceutical Manufacturing (Chennai)
🏢 BVR People Consulting
📍 Chennai