Job description for Quality Control Manager in pharmaceutical formulation

Job Description: Quality Control (QC) Manager Pharmaceutical Formulation

Job Title

Quality Control (QC) Manager – Asst. Manager - Pharmaceutical Formulation/ Nutraceutical

Department

Quality Control

Reports To

Plant Head / Managing Director

Job Summary

The Quality Control Manager is responsible for planning, organizing, and managing all quality control activities in a pharmaceutical formulation manufacturing facility. The role ensures that raw materials, packaging materials, in-process samples, finished products, stability samples, and water systems are tested in compliance with Good Manufacturing Practices (GMP), regulatory requirements, and company quality standards.

Key Responsibilities

- Manage the day-to-day operations of the Quality Control laboratory.
- Ensure testing of raw materials, packaging materials, in-process samples, finished products, stability samples, and water samples.
- Review and approve analytical reports, Certificates of Analysis (CoA), specifications, and laboratory records.
- Ensure compliance with c GMP, GLP, ICH, WHO, US FDA, EU GMP, MHRA, and other applicable regulatory guidelines.
- Oversee analytical method validation, method transfer, verification, and cleaning validation support.
- Review and approve Standard Operating Procedures (SOPs), specifications, protocols, and reports.
- Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), laboratory incidents, and deviations; implement effective CAPA.
- Ensure calibration, qualification, and preventive maintenance of laboratory instruments.
- Manage laboratory documentation in compliance with ALCOA+ data integrity principles.




- Coordinate stability studies and monitor stability program activities.
- Participate in internal audits, customer audits, and regulatory inspections.
- Ensure timely release of raw materials and finished products.
- Lead laboratory investigations and risk assessments.
- Monitor laboratory KPIs and implement continuous improvement initiatives.
- Manage laboratory inventory, reference standards, reagents, chemicals, and consumables.
- Train and develop QC personnel on GMP, GLP, safety, and analytical procedures.
- Coordinate with Production, QA, R&D;, Regulatory Affairs, and Warehouse departments.

Required Technical Skills

- Solid knowledge of pharmaceutical formulation quality control.
- Hands-on experience with:
- HPLC
- GC
- UV-Visible Spectrophotometer
- FTIR
- Dissolution Tester
- Karl Fischer Titrator
- TOC Analyzer
- Particle Size Analyzer (where applicable)
- Knowledge of analytical method development and validation.
- Familiarity with LIMS, Empower, Lab Solutions, or similar chromatography software.
- Understanding of pharmaceutical microbiology (preferred).
- Knowledge of data integrity and computerized laboratory systems.

Qualifications

- M. Pharm / B. Pharm / M.Sc. (Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or related discipline).
- Additional certifications in GMP, GLP, Six Sigma, or Quality Management are advantageous.

Experience





- 5–15 years of experience in pharmaceutical formulation quality control.
- At least 3–5 years in a managerial or supervisory role.
- Experience in US FDA, MHRA, EU GMP, WHO GMP, or other regulated manufacturing environments is preferred.

Key Competencies

- Leadership and team management
- Analytical and problem-solving skills
- Decision-making ability
- Excellent documentation practices
- Communication and interpersonal skills
- Regulatory compliance knowledge
- Time management and organizational skills
- Attention to detail
- Risk assessment and CAPA management

Key Performance Indicators (KPIs)

- On-time batch release.
- Laboratory turnaround time (TAT).
- OOS/OOT investigation closure within target timelines.
- Audit readiness and inspection outcomes.
- Data integrity compliance.
- Instrument uptime and calibration compliance.
- Training completion and competency levels.
- Reduction in laboratory deviations and repeat analyses.

Working Conditions

- Pharmaceutical formulation manufacturing facility.
- Compliance with laboratory safety, GMP, and PPE requirements.
- May require support during audits, regulatory inspections, validation activities, and production emergencies.

Preferred Knowledge

- Current Good Manufacturing Practices (c GMP)
- Good Laboratory Practices (GLP)
- ICH Guidelines (Q2, Q3, Q6)
- 21 CFR Part 11
- Data Integrity (ALCOA+)
- Stability guidelines
- Risk Management (ICH Q9)
- Pharmaceutical Quality System (ICH Q10)

This job description is suitable for QC Manager positions in pharmaceutical formulation plants manufacturing tablets, capsules, Powders, Gummies oral liquids, and other dosage forms.

Email: [email protected] , Mobile : (phone hidden)

📌 Quality Control Manager (Telangana)
🏢 Lactonova Nutripharm
📍 Telangana