Job Description
Role & responsibilities
Reporting To :- Plant Head
Role Purpose
The QC Manager is responsible for establishing, operating, and continuously improving the Quality Control function to ensure that all raw materials, in-process samples, finished products, utilities, and stability samples are tested and released in compliance with applicable regulatory requirements, pharmacopeial standards, and internal quality systems.
Key Responsibilities
1. Laboratory Operations & Control
- Establish and manage Chemical, Instrumentation, and Microbiology QC laboratories (as applicable).
- Ensure timely sampling, testing, documentation, and release of:
- Raw materials
- Packaging materials
- In-process samples
- Finished products
- Stability samples
- Utilities (PW, purified water, compressed air, etc.)
- Plan and manage daily testing priorities to avoid production delays.
2. Compliance & Regulatory
- Ensure compliance with:
- Schedule M
- WHO-GMP
- Applicable pharmacopeias (IP, BP, USP, EP)
- Prepare QC systems for:
- Regulatory inspections
- Customer audits
- Internal audits
- Support regulatory submissions and responses related to QC data.
3. Documentation & Data Integrity
- Prepare, review, and approve:
- Test methods and specifications
- SOPs, STPs, protocols, and reports
- Certificates of Analysis (COA)
- Ensure ALCOA+ data integrity principles are followed.
- Review analytical raw data, chromatograms, and laboratory records.
4. Instrumentation & Calibration
- Oversee qualification, calibration, and maintenance of QC instruments including (as applicable):
- HPLC, GC, UV, FTIR
- Dissolution apparatus
- pH meters, balances, stability chambers
- Ensure proper handling of reference standards, working standards, and reagents.
5. Method Validation & Verification
- Plan and execute:
- Analytical method validation
- Method transfer and verification
- Investigate and close:
- Out-of-specification (OOS)
- Out-of-trend (OOT)
- Laboratory deviations
6. Stability & Shelf-Life Studies
- Design and manage stability programs as per regulatory requirements.
- Monitor stability data and trend analysis.
- Recommend shelf life and storage conditions.
7. Team Management & Training
- Build and manage the QC team including analysts and executives.
- Conduct training on:
- GMP practices
- Analytical techniques
- Data integrity
- Evaluate team performance and identify skill gaps.
8. Cross-Functional Coordination
- Coordinate closely with:
- Production
- QA
- Engineering
- Stores and Purchase
- Support investigations related to:
- Process deviations
- Market complaints
- Product quality issues
Educational Qualifications
- M.Sc. / B.Pharm / M.Pharm (Pharmaceutical Chemistry, Analytical Chemistry, or related discipline)
Experience Requirements
- 812 years of experience in QC within pharmaceutical manufacturing
- Minimum 35 years in a managerial or supervisory QC role
- Hands-on exposure to regulated manufacturing environments is mandatory
Key Skills & Competencies
- Strong understanding of GMP and regulatory requirements
- Hands-on analytical expertise
- Investigation and root cause analysis skills
- Documentation and audit readiness
- Team leadership and decision-making ability
- Ability to work in fast-paced manufacturing environments
Preferred Experience (Good to Have)
- Greenfield plant setup experience
- Exposure to regulatory inspections (WHO, State FDA, etc.)
- Experience with OSD / topical / sterile (as applicable to plant)
Key Performance Indicators (KPIs)
- Timely material and product release
- Audit observations related to QC
- OOS/OOT closure timelines
- Laboratory compliance and up-time
- Training effectiveness and team capability
Working Conditions
- Full-time, factory-based role
- May require extended hours during audits, validations, or investigations
How to Apply
Interested candidates may apply by sending the following documents via email:
- Updated CV / Resume
- Cover Letter explaining why you are suitable for this role and your experience with QC systems, audits, and pharmaceutical compliance
Email your application to: gursimarpharma@gmail.com
Subject Line: Application – QC Manager