QMS Executive API Plant

About Us:

Fido Pharma is a leading pharmaceutical manufacturer committed to ensuring the highest standards of product quality, safety, and compliance. We are seeking a dedicated and detail-oriented API Plant QMS Executive to support and maintain the Quality Management System within our API manufacturing facility. The ideal candidate will ensure compliance with regulatory standards and internal SOPs, driving continuous improvement and maintaining documentation integrity.

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.
• Proficiency with QMS software/tools and MS Office applications.

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:
Send your resume to hrd@fidopharma.com

Job Type: Full-time

Pay: ₹15,000.00 - ₹35,000.00 per month

Work Location: In person