Manager – Quality Assurance

4 weeks ago

Baddi, India Panacea Biotec Full time

Job Summary:

Responsible for overall Quality Assurance function of Food and Nutrition Division by formulating the strong Quality Management System & by implementing the cGMP /GLP /GDP at Food and Nutrition Block /Contract Manufacturing Site of Panacea Biotec Pharma Limited, Baddi.


Job Responsibilities:


  • To implement quality policies and procedures and to ensure their compliance in Food and Nutrition site/ Contract Manufacturing Site
  • To formulate Quality Management Systems to ensure cGMP / GLP / GDP compliance at manufacturing, laboratory, warehouse and engineering to meet current regulatory standards.
  • To Authorize/Approve the Standard Operating Procedures, Standard Test Procedures, Specifications, Technical Documents (TDs), Protocols and reports, APQRs etc.
  • To co-ordinate for audits by the external agencies, regulatory authorities and formation of response to regulatory authorities and customers
  • To conduct internal quality audits to review the implementation of systems as per the design to ensure cGMP compliance at site.
  • To ensure proper training & development of all QA personnel.
  • To release or reject or hold the batch of finished products for sale and distribution.
  • To ensure the distribution, retrieval, archival, storage and retention of all records related to plant.
  • To ensure the vendors approval and approval of contract manufacturing sites as per company’s standard operating procedures including compliance to quality system.
  • To ensure safety measures in the operation of plant.
  • To evaluate the performance of quality assurance department personnel
  • Responsible for disposition and Authorization of Change Controls, Incidents, Deviations, OOS, OOTs non- conformance report (NCRs) Yield nonconformance report (YNCRs), market complaints and Corrective actions & Preventive Actions (CAPA).

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