Manager - Quality Assurance

Direct and oversee all Quality Assurance functions within the manufacturing facility.

Guarantee strict adherence to cGMP, DGDA guidelines, and relevant quality management standards.

Create, execute, and refine Quality Assurance strategies, standard operating procedures (SOPs), and quality frameworks.

Evaluate and authorize batch records, validation plans, hardware qualifications, change requests, non-conformances, CAPAs, and investigations.

Integrate robust risk management practices and strict data integrity standards throughout QA workflows.

Organize internal reviews, self-assessments, vendor audits, and official regulatory inspections.

Track performance benchmarks and spearhead continuous quality improvement programs.

Offer technical advice, mentorship, and professional development support to the QA personnel.

Partner with Production, QC, Engineering, Storage, and Regulatory teams to preserve product standards and legal compliance.

Assist in launching new products, technology transfers, and process or cleaning validation protocols.

Maintain complete inspection readiness and ensure the prompt resolution of all audit findings.