1. Quality Management System (QMS) Executive
Job Title:
Quality Management System (QMS) Executive
Location:
Chennai
Experience:
16 Years
Qualification:
B.Pharm / M.Pharm / M.Sc (Chemistry, Life Sciences, Pharmaceutical Sciences)
Key Responsibilities:
- Preparation, review, issuance, revision, and archival of GMP documents.
- Management of SOPs, Specifications, STPs, Formats, and Logbooks.
- Handling Change Controls, Deviations, CAPA, OOS, OOT, and Risk Assessments.
- Preparation and review of Annual Product Quality Review (APQR/PQR).
- Coordination of Internal, Customer, and Regulatory Audits.
- Review and control of Quality Management System documentation.
- Trending of QMS metrics and compliance monitoring.
- Ensure compliance with GMP, GDP, Data Integrity, and regulatory requirements.
Skills Required:
- Documentation
- Change Control
- CAPA
- Deviation Handling
- Audit Management
- Data Integrity
- GMP / GDP
2. In-Process Quality Assurance (IPQA) Executive
Job Title:
IPQA Executive
Location:
Chennai
Experience:
1–6 Years
Qualification:
B.Pharm / M.Pharm / M.Sc
Key Responsibilities:
- Perform in-process checks during manufacturing and packing activities.
- Line clearance before start-up, product changeover, and batch completion.
- Sampling of raw materials, in-process materials, finished products, and validation batches.
- Review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
- Environmental and personnel monitoring activities.
- Verification of dispensing, manufacturing, and packing activities.
- Investigation support for Deviations, OOS, OOT, and CAPA.
- Ensure compliance with GMP and SOP requirements.
Skills Required:
- IPQA
- Line Clearance
- BMR Review
- BPR Review
- GMP
- GDP
- Documentation
3. Validation & Qualification Executive
Job Title:
Validation & Qualification Executive
Location:
Chennai
Experience:
1–6 Years
Qualification:
B.Pharm / M.Pharm / B.E / M.E / M.Sc
Key Responsibilities:
- Preparation and execution of IQ, OQ, PQ protocols.
- Equipment qualification and utility qualification.
- Process Validation and Cleaning Validation activities.
- Preparation of Validation Master Plan (VMP).
- Thermal Mapping, HVAC Qualification, Water System Qualification.
- Calibration coordination and documentation review.
- Validation report preparation and review.
- Ensure compliance with GMP and regulatory requirements.
Skills Required:
- IQ
- OQ
- PQ
- Equipment Qualification
- Process Validation
- Cleaning Validation
- Utilities Qualification
- Validation Documentation
4. Analytical Quality Assurance (AQA) Executive
Job Title:
Analytical Quality Assurance (AQA) Executive
Location:
Chennai
Experience:
1–6 Years
Qualification:
B.Pharm / M.Pharm / M.Sc (Analytical Chemistry/Chemistry)
Key Responsibilities:
- Review analytical raw data and laboratory documentation.
- Review HPLC, GC, UV, FTIR, Dissolution, and other analytical records.
- Review Analytical Method Validation and Method Transfer documents.
- Review Stability protocols and reports.
- Investigation of OOS, OOT, laboratory deviations, and incidents.
- Ensure ALCOA+ and Data Integrity compliance.
- Support laboratory audits and regulatory inspections.
Skills Required:
- Analytical QA
- HPLC
- GC
- Method Validation
- Data Integrity
- Laboratory Compliance
- GLP
- GMP
5. Stability Executive
Job Title:
Stability Executive
Location:
Chennai
Experience:
1–4 Years
Qualification:
B.Pharm / M.Pharm / M.Sc
Key Responsibilities:
- Management of Stability Study Program as per ICH guidelines.
- Sample withdrawal and distribution to QC laboratory.
- Preparation of Stability Protocols and Reports.
- Monitoring stability chambers and environmental conditions.
- Stability data review and trending.
- Handling chamber excursions and investigations.
- Coordination of stability studies for validation and commercial batches.
- Documentation and regulatory compliance.
Skills Required:
- Stability Studies
- ICH Guidelines
- Stability Chambers
- Stability Protocols
- Data Trending
- Documentation
- GMP
- GLP
Common Details (Applicable to All Roles)
Location: Chennai
Experience: 1–6 Years
Qualification: B. Sc. / M. Sc. B.Pharm / M.Pharm / M.Sc / B.E (as applicable)
Industry: Pharmaceutical / Nutraceutical / CRO / CDMO To Apply:
[email protected]
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📌 QMS / IPQA / AQA / Qualification & Validation / Stability (Chennai)
🏢 Softgel Healthcare
📍 Chennai