Qms Executive Api Plant

2 days ago

Panchkula, India Fido Pharma Pvt. Ltd. Full time

**About Us**:
**Key Responsibilities**:

- Implement, monitor, and maintain the **Quality Management System (QMS)** in the API plant.
- Ensure all activities comply with **cGMP guidelines**, regulatory requirements, and internal policies.
- Manage documentation related to QMS including SOPs, CAPAs, deviation reports, change controls, and audit records.
- Coordinate and support internal and external audits, inspections, and regulatory visits.
- Facilitate training programs related to QMS and GMP compliance for plant personnel.
- Track, investigate, and report on quality incidents, deviations, and non-conformances.
- Support continuous improvement initiatives to enhance quality standards and operational efficiency.
- Liaise with cross-functional teams including Production, QA, QC, and Engineering to ensure QMS adherence.

**Requirements**:

- Minimum **2 years of experience** working in Quality Management or Quality Assurance within an **API manufacturing environment**.
- Bachelor’s degree in Pharmacy, Chemistry, Microbiology, or a related discipline.
- Strong knowledge of **cGMP, ISO standards, and regulatory compliance**.
- Experience in documentation control, audit management, and CAPA processes.
- Excellent communication, organizational, and analytical skills.

**Preferred Qualifications**:

- Experience with **regulatory audits** (FDA, EU GMP, MHRA, etc.) is a plus.
- Knowledge of risk management and root cause analysis methodologies.

**How to Apply**:
Pay: ₹15,000.00 - ₹35,000.00 per month

Work Location: In person

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