Quality Assurance Executive

15 hours ago

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

**Key Responsibilities**:

- **Documentation & Record-Keeping**:

- Maintain and review SOPs, BMRs, BPRs, change control documents, and other QA-related documents.
- Ensure Good Documentation Practices (GDP) are followed.
- **Compliance & Audits**:

- Conduct internal quality audits and prepare CAPA reports.
- Assist in regulatory and customer audits (USFDA, MHRA, WHO, etc.).
- Ensure compliance with cGMP, GLP, and other regulatory requirements.
- **Deviation, CAPA, & Change Control**:

- Investigate deviations and OOS (Out of Specification) incidents.
- Initiate and monitor Corrective and Preventive Actions (CAPA).
- Manage change control documentation and impact assessment.
- **Batch Release & Review**:

- Review completed batch records and analytical data before batch release.
- Participate in decision-making for batch disposition.
- **Training & Awareness**:

- Conduct or coordinate GMP training for production and quality teams.
- Maintain training records and assess training effectiveness.
- **Validation & Qualification**:

- Support in process validation, cleaning validation, and equipment qualification activities.
- Review validation protocols and reports.
- **Continuous Improvement**:

- Participate in Quality Risk Management (QRM) initiatives.
- Suggest improvements to enhance product quality and process efficiency.

Pay: ₹15,000.00 - ₹22,000.00 per month

**Benefits**:

- Provident Fund

Schedule:

- Day shift

Work Location: In person

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