Job Title
Quality Assurance Executive
Department
Quality Assurance (QA)
Reports To
QA Manager / Head of Quality
Job Summary
The Quality Assurance Executive is responsible for ensuring that pharmaceutical products are manufactured, tested, stored, and distributed in compliance with applicable regulatory requirements, Good Manufacturing Practices (GMP), and company quality standards.
Key Responsibilities Documentation & Compliance
- Review and approve Standard Operating Procedures (SOPs), protocols, and reports.
- Ensure compliance with GMP, GLP, GDP, and regulatory requirements.
- Maintain quality management system (QMS) documentation.
- Review batch manufacturing records (BMR) and batch packing records (BPR).
Quality Systems
- Handle deviations, investigations, CAPA (Corrective and Preventive Actions), and change controls.
- Conduct risk assessments and implement mitigation plans.
- Monitor and maintain document control systems.
Audits & Inspections
- Participate in internal audits and self-inspections.
- Support regulatory inspections and customer audits.
- Ensure timely closure of audit observations.
Validation & Qualification
- Review validation protocols and reports for equipment, processes, cleaning, and computerized systems.
- Ensure qualification activities comply with regulatory guidelines.
Training
- Conduct GMP and quality-related training programs.
- Maintain training records and evaluate training effectiveness.
Product Quality Review
- Support annual product quality reviews (APQR/PQR).
- Analyze quality trends and recommend improvements.
Vendor & Supplier Quality
- Assist in supplier qualification and audits.
- Review quality agreements and vendor documentation.
Required Qualifications
- Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology, or related field.
- B.Pharm, M.Pharm, B.Sc., M.Sc. preferred.
Experience
- Freshers to 5+ years (depending on role level).
- Experience in pharmaceutical manufacturing, QA, or regulatory compliance preferred.
Skills Required
- Knowledge of GMP, ICH, WHO, US FDA, EU GMP, and local regulatory requirements.
- Strong documentation and report-writing skills.
- Root cause analysis and CAPA management.
- Attention to detail and problem-solving ability.
- Proficiency in Microsoft Office and quality management software.
Key Performance Indicators (KPIs)
- Audit compliance score.
- Timely closure of deviations and CAPAs.
- Regulatory inspection outcomes.
- Documentation error rate.
- Training compliance percentage.
Pay: ₹15,000.00 - ₹21,000.00 per month
Work Location: In person
