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Process Validation

Keywords / Skills : Process Validation, Process Engineering, PQ, IQ, SQ, SAT, site acceptance testing , PFMEA

6 - 15 years
Posted: 2018-08-18

Nationality
India
Industry
Bio Technology & Life Sciences
Pharmaceutical
Medical Transcription
Function
Pharmaceutical/ Biotechnology
Role
Other Pharma
Posted On
18th Aug 2018
Job Description
· Support the execution / documentation of the site acceptance testing (SAT) and the writing of the summary report.

· Support the writing and execution of the Installation Qualification / Software Qualification (IQ/SQ) protocols and reports

· Support the writing and executions of the Operational Qualification protocols

· Support the writing and executions of the process Performance Qualification protocols

· Support the post-PQ equipment operations

· Technical training of the TBV Process Engineers, technicians and operators to the requirements of the process(es) and equipment documentation.

Work may also include supporting the generation or modification / revision of documents such as:

Process Requirements records for: User Requirements and Specifications (URS), P&ID, Installation drawings, equipment specifications, wiring diagrams, control diagrams, preventive maintenance procedures, calibration requirements/specifications, operating procedure updates.

· Process Failure Mode and Effects Analysis (pFMEA)

Manufacturing Operation Procedures (MOPs, also called Vietnam Manufacturing Operating Procedures, VMP, in TBV)



About Company

A CMMI Level 5 Service Company
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