Role & responsibilities

Quality Control (QC) Manager

Reports To

Head Quality / Plant Head

Experience

10-20 years in Pharmaceutical Quality Control, with at least 35 years in a managerial role.

Qualification

- M.Pharm / M.Sc. (Chemistry, Pharmaceutical Chemistry, Analytical Chemistry, Biotechnology, or Microbiology)
- Additional certifications in GMP, GLP, ISO 17025, or regulatory compliance are an advantage.

Job Summary

The Quality Control Manager is responsible for overseeing all quality control activities within the pharmaceutical manufacturing facility. This includes ensuring that raw materials, packaging materials, in-process samples, finished products, stability samples, and water systems meet established quality standards and regulatory requirements. The role also ensures compliance with cGMP, GLP, WHO-GMP, and applicable national and international regulations.

Key Responsibilities

Laboratory Management

- Manage daily operations of Chemical, Instrumental, and Microbiology laboratories.
- Ensure timely testing and release of raw materials, packaging materials, intermediates, and finished products.
- Maintain laboratory efficiency while ensuring compliance with regulatory requirements.
- Ensure adherence to Good Laboratory Practices (GLP).

Quality Control Operations

- Review and approve analytical testing reports and Certificates of Analysis (COA).
- Approve analytical methods, specifications, and test procedures.
- Monitor laboratory productivity and turnaround times.
- Ensure timely investigation and closure of laboratory incidents.

Instrument Management

- Ensure calibration, qualification, and preventive maintenance of laboratory instruments.

- Oversee operation and maintenance of:
- HPLC
- UPLC
- GC
- UV Spectrophotometer
- FTIR




- Dissolution Tester
- TOC Analyzer
- pH Meter
- Karl Fischer Titrator
- Particle Size Analyzer
- Stability Chambers

Documentation & Compliance

- Review SOPs, specifications, protocols, and analytical methods.
- Ensure compliance with:
- cGMP
- WHO-GMP
- GLP
- Schedule M
- USFDA (where applicable)
- MHRA
- EU GMP
- ISO requirements

- Ensure proper documentation and data integrity (ALCOA+ principles).

Method Validation & Stability

- Review and approve:
- Method Validation
- Method Verification
- Method Transfer
- Cleaning Validation support
- Stability Study protocols and reports

- Monitor ongoing stability studies.

Investigations

- Lead investigations related to:
- Out of Specification (OOS)
- Out of Trend (OOT)
- Laboratory Incidents
- Deviations
- CAPA implementation

- Perform Root Cause Analysis using appropriate investigation tools.

Regulatory Compliance

- Support customer and regulatory audits.
- Prepare laboratory documentation for inspections.
- Respond to audit observations.
- Ensure readiness for regulatory inspections at all times.

Team Leadership

- Lead and mentor QC analysts, chemists, microbiologists, and supervisors.
- Allocate laboratory workload effectively.
- Conduct performance reviews and competency assessments.
- Identify training needs and organize technical training.

Vendor & Material Evaluation

- Approve laboratory reagents,



reference standards, and analytical consumables.
- Evaluate external testing laboratories where applicable.
- Monitor inventory of laboratory chemicals and standards.

Continuous Improvement

- Drive laboratory process improvements.
- Reduce testing turnaround time.
- Improve laboratory efficiency and compliance.
- Implement digital laboratory systems where appropriate.

Required Technical Skills

- Solid knowledge of cGMP and GLP.
- Expertise in analytical chemistry and pharmaceutical testing.
- Hands-on knowledge of HPLC, GC, UV, FTIR, dissolution testing, and stability studies.
- Experience with LIMS, ERP, and laboratory documentation systems.
- Good understanding of method validation and analytical troubleshooting.
- Knowledge of regulatory guidelines including ICH, WHO, USFDA, and EU GMP.

Soft Skills

- Leadership and team management.
- Strong analytical and problem-solving ability.
- Excellent communication and interpersonal skills.
- Decision-making and conflict resolution.
- Planning and organizational skills.
- Attention to detail.
- Time management.

Key Performance Indicators (KPIs)

- On-time release of raw materials and finished products.
- Reduction in OOS/OOT occurrences.
- Laboratory turnaround time.
- Regulatory audit readiness.
- Instrument calibration and compliance status.
- CAPA closure within timelines.
- Training completion rate.
- Stability study compliance.
- Laboratory documentation accuracy.
- Customer complaint investigation closure.

Preferred Industry Experience

- Pharmaceutical Formulations
- Tablets
- Capsules
- Syrups
- Ointments
- Creams
- Injectables
- Ophthalmics
- Cosmetics (preferred)
- Nutraceuticals (preferred)

📌 Qc Manager (Dehradun)
🏢 Viencee Pharma Science
📍 Dehradun