QA QC Manager

Role & responsibilities

• Implement and maintain the Quality Management System (QMS).
• Ensure compliance with CGMP, GMP, SOPs, and regulatory requirements.
• Oversee QA and QC department activities.
• Review and approve batch records, laboratory records, and product release.
• Approve validations, qualifications, and GMP documents.
• Conduct and manage internal and external audits and ensure timely CAPA.
• Review and approve OOS, OOT, deviations, change controls, and complaints.
• Ensure timely Annual Product Quality Reviews (APQR).
• Manage training, induction, and performance evaluation.
• Ensure equipment, utilities, and systems remain in a qualified state.
• Handle regulatory inspections, certifications, and third-party audits.
• Prepare, review, and approve quality and technical agreements.
• Implement Quality Risk Management and continuous improvement.
• Coordinate documentation for regulatory submissions and filings.
• Communicate quality-related matters to management and stakeholders.
• Approve finished product batch release.
• Identify, audit, and manage external laboratories and vendors.
• Ensure quality KPIs, cost control, and efficiency targets are met.
• Build strong internal and external quality relationships.
• Perform additional responsibilities as assigned by management.

Preferred candidate profile

• Graduate/Postgraduate in Pharmacy, Chemistry, or related discipline
• Strong knowledge of CGMP, QMS, and regulatory requirements
• Experience in QA & QC operations in pharmaceutical manufacturing
• Hands-on experience with audits, validations, and regulatory inspections
• Sound understanding of OOS, OOT, CAPA, deviations, and change control
• Experience in batch release and APQR activities
• Good leadership, communication, and team management skills
• Ability to handle multiple regulatory authorities and third-party audits
• Strong documentation, analytical, and problem-solving skills

Please share resume email us on hr@celluloseankit.com or whatsapp on 7666900219