Executive - QC

Experience: Not Available to Not Available years

Location: Corporate Office, Ahmedabad, Gujarat, India

Skills: Pharmaceutical Quality Control systems, Analytical techniques, cGMP, GLP, Documentation practices, LIMS Calibre, MS Office, HPLC, GC, UV, IR

Key Result Areas (KRAs)
1. Analytical Testing & Laboratory Operations
• Perform and monitor testing of:
1. Raw Materials (RM)
2. Packaging Materials (PM)
3. In-process samples
4. Finished products
5. Stability samples
• Ensure testing activities are carried out as per approved specifications, STPs, and regulatory requirements.
• Ensure timely release of materials and products without impacting production timelines.

2. Documentation & Specification Management
• Prepare, review, and maintain:
1. Specifications
2. Standard Test Procedures (STPs)
3. Methods of Analysis (MOA)
4. Records of Analysis (ROA)
5. Analytical reports and laboratory records
• Ensure compliance with Positive Documentation Practices (GDP) and data integrity requirements.

3. LIMS & Laboratory Data Management
• Manage LIMS-related activities including:
1. Master data creation
2. Specification management
3. Analytical data entry
4. MOA/ROA preparation
• Ensure accuracy, integrity, and traceability of laboratory data.

4. Method Validation & Analytical Support
• Participate in:
1. Method validation
2. Method verification
3. Method transfer activities
4. Analytical troubleshooting
• Support analytical activities related to technology transfer and new product introduction.

5. Regulatory Compliance & Quality Systems
• Ensure compliance with:
1. cGMP
2. GLP
3. MHRA
4. USFDA
5.



Other applicable regulatory guidelines
• Maintain laboratory readiness for internal, customer, and regulatory audits.

6. SOP & Policy Management
• Draft, review, revise, and implement:
1. SOPs
2. Quality policies
3. Validation policies
4. Cleaning validation policies
5. Calibration procedures
6. Training procedures
• Ensure periodic review and compliance of controlled documents.

7. Investigation & Compliance Management
• Support and participate in:
1. Deviations
2. OOS (Out of Specification)
3. OOT (Out of Trend)
4. CAPA
5. Change Control investigations
• Ensure timely investigation closure and implementation of corrective/preventive actions.

8. Cross Functional Coordination
• Coordinate with:
1. QA
2. Production
3. Regulatory Affairs
4. Warehouse
5. Technical Services
• Ensure smooth execution of quality-related activities and timely issue resolution.

9. Regulatory Submission & Audit Support
• Support preparation and compilation of documents required for:
1. Regulatory submissions
2. Customer audits
3. Regulatory inspections
• Assist during MHRA, USFDA, and customer audits by providing QC-related documents and data.

Additional Tasks / Responsibilities
• Maintain calibration and preventive maintenance records for laboratory instruments.




• Ensure proper handling, storage, and disposal of laboratory chemicals and reagents.
• Monitor laboratory housekeeping and compliance with safety procedures.
• Maintain analytical reference standards, working standards, and inventory records.
• Participate in stability study activities and sample management.
• Review analytical trends and report abnormal observations to management.
• Ensure timely completion of laboratory documentation and archival activities.
• Assist in training junior analysts and laboratory personnel on SOPs and analytical practices.
• Support implementation of data integrity and laboratory compliance initiatives.
• Participate in continuous improvement projects related to laboratory efficiency and compliance.
• Coordinate with external laboratories/vendors for outsourced testing activities when required.
• Ensure adherence to EHS (Environment, Health & Safety) requirements within the laboratory.

Essential Skills & Competencies
• Solid knowledge of:
1. Pharmaceutical Quality Control systems
2. Analytical techniques
3. cGMP & GLP requirements
4. Documentation practices
• Experience working in MHRA and USFDA-approved manufacturing facilities.
• Understanding of pharmaceutical dosage form manufacturing processes.
• Proficiency in:
1. LIMS Calibre is must
2. MS Office
• Strong analytical, technical writing, and problem-solving skills.
• Ability to work effectively in a regulated and audit-driven environment.

Preferred Skills (Optional)
• Hands-on experience with analytical instruments such as HPLC, GC, UV, IR, etc.

📌 Executive QC (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad