Regulatory Affairs & GMP Specialist

Job description and responsibilities of the proposed candidate(s):

GMP Compliance:

• Monitor adherence to GMP standards across manufacturing, packaging, and storage processes.
• Perform routine audits and inspections to identify and resolve compliance gaps.
• Ensure that all equipment, materials, and processes comply with GMP and regulatory guidelines.

Documentation:

• Review and approve batch records, SOPs (Standard Operating Procedures), and related quality documents.
• Maintain accurate and up-to-date records of GMP activities and compliance measures.
• Ensure timely completion of deviations, CAPAs (Corrective and Preventive Actions), and change controls.

Training & Awareness:

• Conduct GMP training sessions for employees at all levels.
• Develop and update training materials to reflect current regulations and company policies....