Renown Pharmaceuticals is recruiting for the position of QA Officer (Reviewer) in the Quality Assurance department at Vadodara, Gujarat. The role focuses on batch manufacturing and packing record review, product release documentation, deviation and CAPA management, regulatory compliance, document control, and audit support.
Candidates with pharmaceutical manufacturing experience and qualifications in B.Pharm, M.Pharm, B.Sc. Chemistry, or M.Sc. Chemistry can apply based on the listed eligibility criteria.
Job Details
| Particulars | Details |
|---|---|
| Company | Renown Pharmaceuticals |
| Job Title | QA Officer (Reviewer) |
| Department | Quality Assurance |
| Job Location | Vadodara, Gujarat |
| Experience | 2β5 years |
| Employment Type | Full-time, Permanent |
| Industry | Pharmaceutical & Life Sciences |
| Qualification | B.Pharm, M.Pharm, B.Sc. Chemistry, or M.Sc. Chemistry |
| Reporting To | QA Manager / Head Quality Assurance |
Position: QA Officer (Reviewer)
The QA Officer (Reviewer) ensures that manufacturing, packing, testing, and release activities comply with Schedule M, cGMP, and ALCOA+ data integrity requirements. The role involves reviewing quality records and investigations, controlling documentation, supporting audits, and verifying that only quality-approved materials and batches are released.
Roles and Responsibilities
1. Batch Record Review and Product Release
- Review and approve Batch Manufacturing Records (BMR) and Batch Packing Records (BPR) for completeness and cGMP compliance.
- Review in-process, finished product, and stability data against approved specifications.
- Verify Certificates of Analysis (CoA) and release documentation for raw materials, packing materials, and finished goods.
2. Quality Events and Investigations
- Review deviations and coordinate root cause analysis with relevant departments.
- Ensure timely closure of deviations and corrective and preventive actions (CAPA).
- Review Out of Specification (OOS) and Out of Trend (OOT) investigations.
- Review change control requests and assess their quality impact.
- Handle market complaints, product recalls, and returns, including documentation and trend analysis.
3. Documentation and Document Control
- Review, draft, revise, and control SOPs, specifications, protocols, and reports.
- Maintain accurate ERP master data, including Bill of Materials (BOM) updates and item code assignments.
- Ensure compliance with established document control procedures and good documentation practices.
4. Validation, Qualification, and Calibration
- Review IQ/OQ/PQ, process validation, and cleaning validation documents.
- Verify calibration, preventive maintenance, and equipment, instrument, and utility cleaning records.
5. Compliance, Audits, and Training
- Ensure compliance with Schedule M, cGMP, and ALCOA+ data integrity principles.
- Plan and conduct internal audits and self-inspections.
- Support WHO, US FDA, CDSCO, and customer audits by preparing documentation and participating in inspections.
- Conduct GMP training and maintain personnel training records.
- Track audit observations and ensure timely closure.
Eligibility and Qualifications
Educational qualifications:
- B.Pharm
- M.Pharm
- B.Sc. in Chemistry
- M.Sc. in Chemistry
Experience requirements:
- 2β5 years of experience in Quality Assurance within a pharmaceutical manufacturing unit.
- Hands-on experience in BMR/BPR review, deviation and CAPA handling, change control, and SOP management.
Freshers with strong academic performance and internship exposure may be considered for junior roles.
Preferred industry exposure:
- Oral solid dosage, injectables, or API manufacturing, as applicable.
- Experience in a regulated or WHO-GMP-approved facility.
- Participation in at least one regulatory or customer audit, such as WHO, US FDA, or CDSCO inspections.
Required Skills
Technical Skills
- BMR/BPR review and CoA verification
- Quality Assurance and pharmaceutical documentation
- Schedule M and WHO-GMP requirements
- US FDA 21 CFR Parts 210/211
- ICH Q7, Q9, and Q10
- CDSCO regulatory requirements
- Deviation, CAPA, OOS/OOT, and change control
- SOP drafting and good documentation practices (GDP)
- IQ/OQ/PQ, process validation, and cleaning validation
- ALCOA+ data integrity and audit trail review
- Stability data interpretation
- ERP, BOM management, eQMS, and document management systems
- MS Excel and Word
Behavioral Skills
- Attention to detail and documentation accuracy
- Analytical thinking and root cause analysis
- Written and verbal communication
- Cross-functional coordination with Production, QC, Engineering, Warehouse, and Regulatory Affairs
- Time management and adherence to batch release and CAPA timelines
- Ethical conduct, discipline, and teamwork
- Audit and inspection readiness
- Training and presentation skills
Desirable Qualifications
The following are considered additional advantages:
- Training in data integrity and revised Schedule M requirements
- Internal auditor or GMP lead auditor certification
- Experience reviewing process and cleaning validation documents
- Exposure to stability study data review
Key Performance Indicators (KPIs)
Performance in this role is assessed through:
- Timely review and release of batch records
- Closure of deviations, CAPAs, and change controls within defined timelines
- Reduction of documentation errors after QA approval
- Completion of planned training and internal audits
- Audit readiness and timely closure of audit observations
- Accuracy of ERP master data, including BOMs and item codes
