ASSISTANT MANAGER QA

• Preparation of QA Standard Operating Procedures and review of Production and cross functional departments SOP prior to approval.
• Review executed Batch Production records, Deviation & Change controls (if any), Components sterilization details, Legibility, Material reconciliation and Analytical records prior to batch release by QA.
• Perform routine GMP walk through manufacturing department.
• Execution of in-process checks at various stages of Formulation, Filling, Optical Inspection, Labeling, Packing.
• Responsible for day to day operations of Quality Assurance department which include complying of Standard Operating procedures/Protocols and cGMP. Final lot / batch release procedures.
• Collection, storage, Retrieval and destruction of control samples of finished product.
• Statistical Process Controls/Continual Process Improvement.
• Quality Risk Assessment of the process.
• GAP analysis of the SOP's, Batch manufacturing records and Protocols for effective implementation of SOP's & BMR's and to comply with cGMP
• Review and approval of investigations associated with QMS elements like Deviations, change managements & Complaints.
• Review of Master formula record (MFR)/Batch manufacturing records (BMR).
• Review of executed Batch Production records and preparation of review check list.
• Identifying and leveraging opportunities to improve the quality systems and standards.

• Prior experience in handling the In-process /QMS Quality Assurance activities.
• Must have worked with pharmaceutical and / or Biopharmaceutical products.
• Should have hands on experience in handling investigations related to manufacturing, packing and testing.
• Should have hands on experience in data analysis and all other critical Quality Management Systems.
• Experienced in handling regulatory audits such as EMEA/ USFDA audits.

MSc / MPharma /BPharma