Deputy Manager Quality Assurance & Regulatory Affairs

We are seeking an experienced professional to lead Quality Assurance while supporting Regulatory Affairs activities at our API manufacturing facility. The ideal candidate will be responsible for ensuring overall compliance with QMS and regulatory standards, managing validations and audits, and maintaining product quality in line with international guidelines.

Key Responsibilities:

• Lead The implementation and oversight of the site Quality Management System (QMS), including SOPs, validations, and document control.
• Conduct and manage internal and vendor audits; review deviations, non-conformances, and ensure timely CAPA execution.
• Review and approve Master Production Records, Batch Production Records, and Validation Protocols across departments.
• Coordinate process, cleaning, and analytical method validations as per the Validation Master Plan.
• Prepare, review, and manage regulatory documentation including DMFs/ASMFs in CTD format (Modules 1, 2, 3).
• Liaise with regulatory authorities and customers for audit readiness, document submissions, and compliance queries.
• Oversee training programs for plant personnel and ensure continuous adherence to GMP standards.
• Conduct Product Quality Reviews and implement risk management tools like FMEA, HACCP, and HAZOP where applicable.

General Requirements:

• Thorough understanding of global regulatory guidelines (ICH, WHO, USFDA, etc.).
• Strong analytical, documentation, and decision-making skills.
• Proficient in regulatory submissions and quality review documentation.
• Familiarity with stability studies and establishing expiry/retest periods.
• Hands-on experience with validation protocols and equipment calibration systems.
• Ability to lead cross-functional teams and ensure site-wide compliance.
• Excellent verbal and written communication skills.
• Willingness to take ownership and drive continuous improvement initiatives.