Manager Quality Assurance

Vizor, an Acuraglobe company is hiring QA Assurance for a leading pharmaceutical client.

The Manager - Quality Assurance is responsible for creating Quality culture, implementation of Quality systems, SOP and regulatory requirements to ensure plant excels in Quality and is Audit ready at all times.

• Responsible for effective implementation of pharmaceutical quality systems in accordance with company's quality policies & regulatory requirements.
• To ensure the product manufactured in the plant and meet the requirement as per the standard operating procedure and cGMP aspects.
• To review & approve of master documents like SMF, VMP, Batch records, (BMRs & BPRs), written procedures, sampling instructions, specifications, test methods, all Qualifications / Validations protocols & reports including amendments. Facility layouts review & approval.
• To review & approval of QMS documents like Change Controls, Deviations, Product Recalls, Non- Conformance, OOS & OOT and implementation of CAPA
• To carryout investigation for all QMS related activities, identify root cause, prepare corrective and Preventive action plan for Deviations and to ensure the compliance in coordination with other functional departments
• Responsible for handling of market complaints through proper investigation and implementation of CAPA.
• To approve or reject the finished products as per specifications (Batch Release). Reject the starting materials, packing materials, intermediates not meeting the specification limits
• To review & approval of Risk assessments for Facility, Equipments, Utilities & Products etc.
• To Review and Approval of Quality Manual.
• To Review & Approval of Art Works.
• To Review & Approval of Annual Product Quality reviews.
• To Review & Approval of Environment monitoring & Trend in Water system testing.
• To maintain & ensure the Data integrity and Data governance system in the plant.
• To ensure that all necessary testing is carried out. Review & approval of stability data and ensure the quality of the product.
• Monitoring of plant hygiene.
• To lead GMP, regulatory/customer audits & CAPA compliance.
• Review & approval of Calibration & Preventive maintenance schedules.
• To ensure that the appropriate validations are carried out as per VMP planner.
• Responsible for imparting of GMP trainings & Technical Trainings.
• Ensure self-inspections are conducted as per the schedule & compliance.
• Review & approval of Vendor Documents for Raw Materials & Packing Materials, Contract manufacturing, Contract Testing Laboratories, To ensure supply of products and service of acceptable standards.
• Review & Approval of External Service Providers Qualifications.
• Responsible for compliance with regulatory requirements related to the quality.
• Monitoring and control of the manufacturing environment.
• Performance and evaluation of in-process controls, inspections, line clearances monitoring of compliance with GMP requirements.
• Monitoring of All Documentation related Activities.
• Lead site quality management review meeting & ensure compliance.
• To co-ordinate with other departments for introduction of new products or new process as per the developmental studies or the marketing authorization requirements.
• Review & approval of technical agreements from customers/ external agencies.
• To investigate product recalls if any & ensure it is performed successfully in line with approved procedures.
• To approve and authorized destruction of rejected materials/batches.
• As senior member of management team, participate and contribute in achieving company objectives, as directed by the management from time to time.