JOB DESCRIPTION (JD)Position: Head – Quality Control (QC)

Company: Azentyx Health Care Pvt. Ltd.
Department: Quality Control (QC)
Designation: Head – Quality Control
Reporting To: Head – Quality Assurance / Plant Head / Management, as per organization structure
Location: Barotiwala, Baddi (H.P.)

1. Job Purpose

To lead and manage the Quality Control Department, ensuring that all raw materials, packing materials, in-process samples, finished products and stability samples are tested, evaluated and released in accordance with approved specifications, WHO-GMP guidelines and applicable regulatory requirements.

2. Key Responsibilities

A. Quality Control Operations

- Lead and supervise all QC activities, including Chemical, Instrumental, Microbiology and Stability testing.
- Ensure timely sampling, testing, analysis and reporting of raw materials, packing materials, intermediates and finished products.
- Review and approve analytical results, test reports and Certificates of Analysis (COA).
- Ensure proper functioning, calibration and maintenance of laboratory instruments and equipment.
- Monitor laboratory performance and ensure adherence to approved specifications and test methods.

B. GMP & Regulatory Compliance

- Ensure implementation and compliance with WHO-GMP, Schedule M and applicable regulatory requirements.
- Ensure proper documentation and data integrity in accordance with ALCOA+ principles.
- Handle regulatory inspections and customer audits related to the QC Department.
- Ensure compliance with approved SOPs, specifications, STPs and analytical methods.
- Ensure proper maintenance of QC records, registers and laboratory documentation.

C. OOS, OOT & CAPA Management

- Investigate and review Out of Specification (OOS) and Out of Trend (OOT) results.
- Ensure timely implementation of CAPA and root cause analysis.
- Review laboratory deviations, incidents and atypical results.
- Ensure appropriate corrective and preventive actions to avoid recurrence.

D. Stability & Validation





- Supervise stability studies as per approved protocols and applicable guidelines.
- Ensure preparation and review of stability protocols and reports.
- Coordinate analytical method validation and verification.
- Ensure proper handling, storage and monitoring of stability samples.

E. Team Management

- Lead, guide and supervise QC Managers, Officers, Chemists and Microbiologists.
- Allocate responsibilities and monitor departmental performance.
- Conduct regular training on GMP, GLP, safety and laboratory practices.
- Evaluate employee performance and identify training requirements.
- Ensure adequate manpower and effective utilization of departmental resources.

F. Equipment & Laboratory Management

- Ensure calibration, qualification and preventive maintenance of QC instruments.
- Maintain laboratory cleanliness, safety and housekeeping standards.
- Ensure availability of chemicals, reagents, reference standards and consumables.
- Monitor laboratory environmental conditions wherever applicable.
- Ensure proper handling and disposal of laboratory waste.

G. Coordination & Reporting

- Coordinate with QA, Production, Warehouse, Engineering and Regulatory Affairs.
- Ensure timely communication of critical quality issues to QA and Management.
- Participate in quality review meetings and management review meetings.
- Prepare and monitor departmental KPIs and performance reports.

3. Educational Qualification

- M.Sc. in Chemistry / Pharmaceutical Chemistry / Analytical Chemistry or M.Pharm.
- Relevant specialization in Pharmaceutical Quality Control preferred.

4. Experience





- 8–12 years of relevant experience in the pharmaceutical industry.
- Minimum 3–5 years of experience in a managerial or leadership role.
- Experience in pharmaceutical formulations and WHO-GMP manufacturing facilities preferred.

5. Required Skills & Competencies

- Strong knowledge of WHO-GMP and Schedule M.
- Knowledge of HPLC, GC, UV, FTIR and other analytical instruments.
- Knowledge of OOS, OOT, CAPA, deviations and change control.
- Strong analytical, problem-solving and decision-making skills.
- Excellent leadership and team management abilities.
- Knowledge of stability studies and analytical method validation.
- Strong documentation and regulatory audit-handling skills.

6. Key Performance Indicators (KPIs)

- Timely completion of raw material and finished product testing.
- Accuracy and reliability of analytical results.
- Timely closure of OOS, OOT, deviations and CAPA.
- Compliance with WHO-GMP and regulatory requirements.
- Reduction in laboratory errors and documentation discrepancies.
- Timely calibration and qualification of laboratory instruments.
- Successful completion of internal and external audits.
- Training effectiveness and departmental performance.

7. Authority & Accountability

- Responsible for overall functioning of the QC Department.
- Authorized to review and approve QC analytical reports within delegated authority.
- Responsible for recommending material/product status based on QC results.
- Responsible for ensuring that testing and reporting are performed as per approved procedures.
- Accountable for maintaining laboratory compliance and data integrity.

8. Declaration

I have read and understood the above Job Description and agree to perform the duties and responsibilities assigned to me.

Pay: ₹90,000.00 - ₹120,000.00 per month

Benefits:

- Adaptable schedule
- Food provided
- Health insurance
- Leave encashment
- Life insurance
- Paid sick time
- Provident Fund

Work Location: In person

📌 Qc Head (Baddi)
🏢 AZENTYX HEALTHCARE
📍 Baddi