Head – Quality Assurance | Acme Generics | Baddi

Job Description

• To ensure cGMP Compliance in the plant.
• To review and approve all departments’ Standard Operating Procedure.
• To ensure compliance with all Standard Operating Procedures.
• Strategic Planning & execution of Quality Management System.
• To ensure the compliance of the Quality Management system as per the requirement.
• Responsible for leading the external audit & providing compliance in a timely manner.
• To review and approve the Site Manager File (SMF), Validation Master Plan(VMP), and Quality manual.
• Responsible for the approval and release of the Batch.
• To review & approve specifications, Standard Test Procedure (STP), and General Test Procedure (GTP) of the Quality Control Department.
• Responsible for Self Inspection or Internal Audit and its compliance.
• To review and approve all Validation and Qualification Protocols and Reports.
• To ensure the compliance of Vendor Audits and approval of Contract Laboratory.
• Perform laundry audits in coordination with the HR department.
• To impart training on different topics including cGMP and GDP etc.
• To coordinate during technology transfer of products to the sites.
• To ensure that products are manufactured as per the approved procedure.
• Responsible for the investigation of the market complaints, Product recall & compliances.
• Responsible for review, approval, and implementation, and verification of Corrective Action and Preventive Action.
• To provide compliance reports of audits.
• To give the final approval for Art Works.
• To conduct interviews and recruitments of Quality Assurance Personnel.
• To ensure the Qualification and Re-qualification of the Equipment, Facility, and System
• Responsible for review and approval of Stability Protocol and report.
• To ensure work discipline in the department.
• Responsible for quality agreement and its compliance.
• To review and approve all apex documents.

Qualification: B.Pharma, M.Pharma, MS/M.Sc