Quality Assurance In-charge

3 days ago

Ambernath Thane Maharashtra, India Dr. Palep's Medical Research Foundation Pvt. Ltd. Full time

**Key Responsibilities**:

- **Quality System Management**:

- Oversee implementation and maintenance of Quality Management System (QMS).
- Monitor compliance with cGMP guidelines, SOPs, and regulatory requirements.
- **Documentation & Record Review**:

- Approve and control SOPs, batch records (BMR/BPR), validation protocols, and reports.
- Review and release of finished product batches after thorough documentation check.
- **Audit Handling**:

- Lead internal and external audits (Regulatory, Customer, Third-party).
- Prepare audit readiness plans and ensure timely closure of audit observations with CAPA.
- **Deviation, OOS, and CAPA Management**:

- Review and approve deviation reports, OOS investigations, and root cause analysis.
- Ensure effective implementation and monitoring of CAPAs.
- **Validation & Qualification Oversight**:

- Supervise and approve process validation, cleaning validation, equipment qualification.
- Review validation master plan and coordinate with concerned departments.
- **Training & Compliance**:

- Develop and execute training programs on GMP, documentation practices, and quality compliance.
- Maintain training records and ensure staff competence.
- **Change Control & Risk Management**:

- Evaluate and approve change controls, risk assessments, and impact analysis on quality.
- Promote quality risk management throughout the facility.
- **Team Leadership**:

- Guide and supervise the QA team.
- Ensure team productivity, skill enhancement, and performance management.

Pay: ₹30,000.00 - ₹40,000.00 per month

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Work Location: In person

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