Position: Senior Executive – Quality Control (QC)

Department: Quality Control (QC)
Designation: Senior Executive – QC
Industry: Pharmaceutical / API Manufacturing
Reports To: QC Manager / Head – Quality Control
Location: Manufacturing Plant

1. Job Purpose

To ensure effective implementation of Quality Control activities, including sampling, testing, analysis, documentation and release of raw materials, intermediates, finished products and stability samples, in compliance with cGMP, GLP, applicable regulatory requirements and company quality standards.

2. Roles and Responsibilities

A. Quality Control Operations

- Perform and supervise testing of raw materials, packing materials, intermediates, in-process samples and finished products.
- Ensure timely analysis and reporting of samples as per approved specifications and standard test procedures.
- Review analytical results, laboratory records and test reports for accuracy and compliance.
- Ensure proper handling, storage and identification of samples and reference standards.
- Coordinate with Production, QA, Warehouse and other departments for routine QC activities.

B. Instrumentation and Laboratory Management

- Ensure proper operation, calibration and maintenance of laboratory instruments such as HPLC, GC, UV, FTIR, pH meter and other analytical equipment.
- Ensure instruments are maintained in qualified and calibrated conditions.
- Monitor laboratory housekeeping, safety and good laboratory practices.
- Ensure availability of chemicals, reagents, solvents, glassware and laboratory consumables.

C. Documentation and Compliance

- Prepare,



review and maintain analytical documents, worksheets, laboratory records and certificates of analysis (COA).
- Ensure compliance with cGMP, GLP, SOPs and applicable regulatory guidelines.
- Participate in internal audits, customer audits and regulatory inspections.
- Ensure proper documentation practices in accordance with ALCOA+ principles.
- Assist in preparation, revision and implementation of SOPs and analytical methods.

D. Quality Management System

- Investigate Out of Specification (OOS) and Out of Trend (OOT) results.
- Participate in deviation, incident and laboratory investigation activities.
- Initiate and implement CAPA wherever required.
- Support analytical method validation, method verification and method transfer activities.
- Participate in change control and continuous improvement initiatives.

E. Stability and Validation Activities

- Perform and coordinate stability sample analysis as per approved stability protocols.
- Maintain stability chamber monitoring records and coordinate calibration activities.
- Support analytical method validation and cleaning validation sample analysis.
- Ensure timely completion of stability studies and preparation of stability reports.

F. Team Management





- Guide and supervise QC analysts and junior executives.
- Allocate daily laboratory activities and monitor work progress.
- Train team members on analytical procedures, SOPs, safety and GMP requirements.
- Ensure effective utilization of laboratory resources and timely completion of testing activities.

3. Educational Qualification

- M.Sc. in Chemistry / Analytical Chemistry / Organic Chemistry.
- B.Sc. in Chemistry may be considered based on relevant experience and company requirements.

4. Experience

- 4–7 years of relevant experience in Quality Control in the pharmaceutical/API manufacturing industry.
- Hands-on experience with analytical instruments such as HPLC, GC, UV and FTIR.
- Knowledge of API analysis, analytical method validation, stability studies and GMP documentation.

5. Technical Skills and Competencies

- Knowledge of cGMP, GLP and applicable regulatory requirements.
- Practical knowledge of HPLC, GC, UV and other analytical instruments.
- Knowledge of OOS, OOT, deviations, CAPA and change control.
- Understanding of analytical method validation and stability studies.
- Good documentation and data integrity practices.
- Problem-solving and analytical skills.
- Team handling and coordination skills.
- Effective communication and reporting skills.

Interested candidates may contact us at Sandhya HR-+91-XXXXXXXXXX for further details.

Candidates who meet the required qualifications and experience are welcome to get in touch.

Pay: ₹500,000.00 - ₹750,000.00 per year

Perks:

- Provident Fund

Work Location: In person

📌 Senior Executive - Quality Control (Navi Mumbai)
🏢 Great Pacific Export
📍 Navi Mumbai