Quality Assurance Specialist

Main Tasks

• Responsible for document management: issuance, storage, retention, and destruction of documents and records as per defined procedures.
• Ensure good documentation by all personnel; keep documents in compliance with current GMP requirements and in‑house SOPs.
• Prepare standard operating procedures and provide training on SOPs.
• Maintain audit documents such as regulatory and customer audit reports and responses.
• Ensure batch production operations are carried out in accordance with cGMP and the procedures mentioned in respective batch records.
• Monitor manufacturing and packing activities on a routine basis; ensure compliance in Warehouse, Manufacturing, and Packing.
• Review batch records, associated data, logbooks, etc., and track monthly batch release activities.
• Review master documents; ensure that cGMP requirements are followed and monitored in critical process areas.
• Participate and ensu...