MQ TS Manager

SV MANAGEMENT CONSULTANTS
  • Visakhapatnam
  • 10-15 lakh
  • 8-12 years
  • 85 Views
  • 29 May 2015
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  • Production/ Manufacturing/ Engineering

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Manufacturing Quality oversight on all TS (Solution Preparation to Sealing). Develop succession planning for the Quality Unit.

Responsibilities -

1.Lead and monitor Quality Oversight for operation from Solution preparation to sealing to ensure compliance to cGMP systems and procedures
2.Managing and coordinating all quality functions within manufacturing area.
3.Ensure manufacturing policies, procedures and standards confirm to predefined regulatory (US FDA/India /EU etc), site standards / specification and corporate standards.
4.Work with manufacturing supervision to resolve issues with compliance.
5.Update SOP/SOI/SCI procedure as necessaryto address continuous improvement opportunity.
6.Update SOP/SOI/SCI procedure as necessaryto address continuous improvement opportunity.
7.Work with manufacturing supervision to resolve issues with compliance.
8.Update SOP/SOI/SCI procedure as necessaryto address continuous improvement opportunity.
9.Conducts data analysis, investigation of processing exception and ensure sufficient resources to revise gap document, corrective action /preventive action and ensuring the effectiveness of these actions.
10.Involve in the site quality audit and identifying corrective and preventive actions.
11.Involve in designing /preparedness of manufacturing of exhibits batch /submission /launch of commercial batches.
12.Ensure Exceptions, online activities, any process changes are followed for manufacturing as per defined site procedure.
13.Ensure Batch manufacturing record review completion.
14.Review, approve and certify master reports documents like SOP, SOI, SCI, batch records, validation protocol and reports.
15.Ensure training and qualification of department personnel
16.Conduct performance reviews with direct reports.
17.Adherence to Safety Procedures/GMP & GDP Practices.
18.Involve in the site quality audit and identifying corrective and preventive actions.
19.Involve in designing /preparedness of manufacturing of exhibits batch /submission /launch of commercial batches.



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SV MANAGEMENT CONSULTANTS