QMS Executive

Key Responsibilities:

• Maintain and update QMS documentation including SOPs, quality manuals, and records.
• Coordinate and support internal and external audits (regulatory and customer).
• Monitor CAPA (Corrective and Preventive Actions) implementation and effectiveness.
• Review and approve change controls, deviations, and non-conformance reports.
• Manage document control systems in compliance with applicable regulatory standards.
• Conduct periodic training and awareness sessions on QMS procedures.
• Assist in risk assessments and quality improvement initiatives.
• Collaborate with cross-functional teams (Production, QA, QC, R&D) to ensure QMS compliance.
• Prepare quality metrics and reports for management review meetings (MRM).
• Ensure compliance with applicable GxP regulations (GMP, GLP, GDP).

Qualifications:

• Bachelor's or Master's degree in Pharmacy, Biotechnology, Microbiology, Chemistry, or related discipline.
• 5–6 years of experience in a QMS or QA role within a regulated industry (pharma/biotech/medical device).
• Familiarity with QMS standards such as ISO 9001, ICH Q10, and cGMP guidelines.