Job Description – Executive / Officer – Corporate Quality Assurance (CQA)
Position: Executive / Officer – Corporate Quality Assurance (CQA)
Location: Sachin, Surat, Gujarat
Department: Quality Assurance
Industry: Pharmaceutical Formulation Manufacturing
Employment Type: Full-Time
Job Summary
The Executive / Officer – Corporate Quality Assurance (CQA) is responsible for maintaining and improving Quality Management Systems (QMS) in compliance with cGMP, regulatory requirements, and company quality standards. The role involves handling audits, deviations, CAPA, change control, risk assessment, and ensuring overall quality compliance across manufacturing operations.
Key ResponsibilitiesQuality Management System (QMS)
- Review and monitor Quality Management System activities.
- Handle Deviations, CAPA, Change Controls, Incidents, OOS, and OOT investigations.
- Ensure timely closure of quality system records.
- Support implementation and continuous improvement of quality processes.
Documentation & Compliance
- Review SOPs, Specifications, Protocols, Reports, and Master Documents.
- Ensure compliance with cGMP, GDP, and regulatory requirements.
- Maintain quality records and documentation as per company procedures.
Audit Management
- Participate in Internal, External, Vendor, and Regulatory Audits.
- Prepare audit compliance reports and track corrective actions.
- Ensure closure of audit observations within defined timelines.
Training & Development
- Conduct GMP and Quality System training programs for employees.
- Monitor training effectiveness and maintain training records.
Risk Management
- Participate in Quality Risk Management activities.
- Support implementation of risk mitigation plans.
- Monitor effectiveness of corrective and preventive actions.
Vendor Qualification
- Assist in vendor qualification and performance evaluation.
- Review vendor-related quality documentation.
Regulatory Compliance
- Ensure compliance with WHO-GMP, Schedule M, and applicable regulatory guidelines.
- Support regulatory inspections and customer audits.
Qualification
- B.Pharm / M.Pharm / B.Sc / M.Sc (Chemistry or Life Sciences)
Experience
- 3 to 6 Years of experience in Corporate Quality Assurance or Quality Assurance in a Pharmaceutical Formulation Company.
Required Skills
- Knowledge of cGMP, GDP, and Quality Systems
- Experience in Deviation, CAPA, Change Control, OOS, and OOT handling
- Documentation and audit management skills
- Good communication and interpersonal skills
- Proficiency in MS Excel, Word, and PowerPoint
- Strong analytical and problem-solving abilities
Salary
CTC: (Based on experience and interview performance)
Benefits
- Provident Fund (PF)
- ESIC as applicable
- Leave Benefits
- Career Growth Opportunities
- Training and Development Programs
Preferred Industry: Pharmaceutical Formulation Manufacturing Only.
Benefits:
Work Location: In person
