Manager - QC - Pharma Industry

GenNext Human Resource Management
  • Gandhidham
  • Confidential
  • 10-15 years
  • 419 Views
  • 22 Jun 2015
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  • Quality Control - Product/ Process

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

1. Administrative: Day to day operations, monitor & control of manufacturing environment. Ensuring release of the raw materials, in-process, bulk and packing materials as per the time lines based on production plan. 2. Adequacy of equipment and facility: Responsible for techno-commercial evaluation and procurement of QC equipments. To ensure that all the equipments and instruments are in validated and calibrated state. 3. Lab instruments and equipment maintenance: 4. Pharmacopeia testing: To carry out pharmacopeia testing analysis in testing analysis in existing products whenever changes in pharmacopoeia and change to implement through change control. 5. Investigation: Out of Specification (OOS) and out of Trend (OOT) investigation Maintenance of summaries and records. 6. Validate Analytical Method: Transfer and validate analytical method. Water analysis and environment control. 7. Statutory / Regulatory / cGMP: cGMP / GLP, World Health Organization (WHO), Schedule M & other international regulatory guidelines. To initiate analyst Food and Drug Administration (FDA) approval, for analysis in chemical analysis, Instrumental analysis & Microbiological analysis. To review the SOPs. To Review and update the GMP manual. To maintain the compliance of the laboratory by implementing online GLP reviews in the laboratory. To review the validation & QC equipment qualification protocol. 8. Regulatory / cGMP: To review the SOPs. To Review and update the GMP manual. To maintain the compliance of the laboratory by implementing online GLP reviews in the laboratory. To review the validation & QC equipment qualification


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