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
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