Head of Quality Assurance

Overall Responsible for Quality Assurance and Quality control function and activities in co-ordination with all the departments.

Review and Approve all site Quality oversight technical and GMP document.

Gap assessment and Remediation to the system, procedures and practices.

Preparation, Review and approve of all site SOP, Protocols, Reports,MFR,BMR,BPR,PV.

Review and approve of all QMS like Deviation,Change control, CAPA, Risk assessment,Investigations, OOS, OOT

Direct facing of all Regulatory and customer Audits, inspections on site .

Preparation of Compliance report and Effective CAPA w.r.t Audit/Inspections

Investigations of Market complaint, Recall if any and effective CAPA implementation.

Direct Experience in all Solid,Liquid, Injection and Sterile injection and Micro department handling is must

Ensuring Daily release of RM/PM/FG as per production and supply and demand of product. Participation in Daily meeting with other department.