QA EXECUTIVE / SENIOR QA EXECUTIVE Regulatory Pharmaceutical Company

Location: Paonta Sahib, Himachal Pradesh
Department: Quality Assurance (QA)
Experience: 5–8 Years
Qualification: B.Pharm / M.Pharm / M.Sc.
Salary: ₹35,000–₹45,000 per month

Key Responsibilities

- Manage and review equipment qualification and validation activities as per GMP and regulatory requirements.
- Prepare, review and execute qualification documents including DQ, IQ, OQ and PQ.
- Handle process validation, cleaning validation and validation protocols/reports.
- Must have practical exposure to Media Fill Validation / Aseptic Process Simulation (APS).
- Coordinate media fill activities, protocol preparation, execution, observations and report compilation.
- Ensure compliance with cGMP, WHO-GMP and regulatory requirements.
- Review validation documents, SOPs, protocols, reports and related QA documentation.
- Coordinate with Production, QC and Engineering departments for qualification and validation activities.




- Support regulatory inspections and audits and ensure timely closure of observations.
- Handle deviations, CAPA, change controls and investigation related to validation activities.
- Maintain proper documentation and ensure data integrity in accordance with applicable guidelines.

Required Skills

- Good knowledge of Equipment Qualification & Validation.
- Strong practical exposure to Media Fill Validation / APS.
- Knowledge of process, cleaning and aseptic validation.
- Good understanding of GMP and regulatory requirements.
- Solid documentation and analytical skills.
- Regulatory exposure is required.
- Good communication and coordination skills.

Preferred Candidate

Candidate should have experience in a regulatory pharmaceutical manufacturing company, preferably with exposure to injectable/aseptic operations and regulatory audits.

Pay: ₹35,000.00 - ₹45,000.00 per month

Benefits:

- Provident Fund

Work Location: In person

📌 QA Executive (India)
🏢 Pharmaceuticals
📍 India