18 Sep
|
Pharmaceuticals
|
Paonta Sahib
18 Sep
Pharmaceuticals
Paonta Sahib
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
Valuable knowledge of Equipment Qualification & Validation.
Solid practical exposure to Media Fill Validation / APS.
Knowledge of process, cleaning and aseptic validation.
Positive understanding of GMP and regulatory requirements.
Robust documentation and analytical skills.
Regulatory exposure is required.
Valuable 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 Paonta Sahib
🏢 Pharmaceuticals
📍 Paonta Sahib