Quality Assurance

6 days ago

Panvel, India Sisco Research Laboratories Pvt. Ltd Full time

**Job Summary**

We are looking for a detail-oriented and system-driven **Quality Assurance (QA) professional** to ensure organization-wide compliance with **GMP, GLP, regulatory standards**, and internal SOPs. This role involves cross-functional coordination with departments such as Production, QC, R&D, Raw Materials, Finished Goods, Maintenance, and Projects/Engineering to maintain quality systems and ensure audit readiness.

**Key Responsibilities**

**1. Quality Control (QC)**
- Review and approval of test methods, specifications, and SOPs.
- Conduct audits focusing on data integrity and documentation practices.
- Investigate and manage Out of Specification (OOS) results and CAPAs.
- Ensure calibration and qualification of laboratory instruments.

**2. Production**
- Approve Batch Manufacturing Records (BMRs), process-related SOPs, and cleaning validation protocols.
- Monitor adherence to cGMP during manufacturing operations.
- Manage deviations, change controls, and the batch release process.

**3. Research & Development (R&D)**
- Review and approve method validations and technology transfers.
- Ensure GLP compliance and documentation traceability.
- Audit R&D processes for data integrity and regulatory readiness.

**4. Raw Material (RM)**
- Approve material specifications and sampling plans.
- Ensure proper vendor qualification and traceability of materials.
- Authorize release or rejection of raw materials based on QC test results.

**5. Finished Goods (FG)**
- Verify packaging and labeling compliance.
- Approve finished product release post complete batch record review.
- Ensure storage and dispatch practices adhere to GMP standards.

**6. Maintenance**
- Ensure maintenance records (preventive and breakdown) meet GMP compliance.
- Review the impact of breakdowns on quality-critical areas.
- Approve equipment qualifications (IQ/OQ/PQ) and oversee calibration schedules.

**7. Projects / Engineering**
- Participate in Design Qualification (DQ) processes.
- Review and approve equipment and facility validations (IQ/OQ/PQ).
- Ensure that utility systems (HVAC, water, cleanrooms) meet GMP requirements.
- Manage change controls and conduct risk assessments during facility upgrades.
- Conduct audits focusing on data integrity and documentation practices.
- Investigate and manage Out of Specification (OOS) results and CAPAs.
- Ensure calibration and qualification of laboratory instruments.

**Requirements**:

- Bachelor's/Master’s degree in Pharmacy, Chemistry, Biotechnology, or related field.
- 1-5 years of QA experience in a pharmaceutical or biotech environment.
- Strong knowledge of GMP, GLP, regulatory guidelines, and quality systems.
- Experience in audits, documentation review, and quality investigations.

**Preferred Skills**
- Good communication and coordination abilities.
- Attention to detail and strong documentation skills.
- Working knowledge of QMS software/tools is a plus.

**Job Types**: Full-time, Permanent

Pay: ₹15,000.00 - ₹21,000.00 per month

**Benefits**:

- Provident Fund

Work Location: In person

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