Job Description

Roles & Responsibilities:

• Ensure compliance with GMP, GLP, and GDP requirements across manufacturing and quality operations.
• Review and approve SOPs, protocols, batch records, and other controlled quality documents.
• Lead and support deviation investigations, CAPA activities, change control, and risk assessments.
• Participate in internal audits, vendor audits, and regulatory inspections (FDA, EMA, WHO).
• Maintain and oversee Quality Management System (QMS) documentation and records.
• Support quality training programs and ensure compliance awareness across teams.
• Review, investigate, and track OOS, OOT, and product complaints.
• Support validation and qualification activities as required.
• Ensure data integrity and adherence to ALCOA+ principles.

• Bachelor's degree in pharmacy, Life Sciences, Chemistry, or a related field.
• 5+ years of Quality Assurance experience in a pharmaceutical environment.
• Strong working knowledge of GMP regulations and FDA guidelines.
• Hands-on experience with documentation control systems and QMS tools.
• Excellent analytical, communication, and problem-solving skills.

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