AM / Manager - Technical Services (process Engineering & Validations)

  • Visakhapatnam
  • 10-15 lakh
  • 7-12 years
  • 19 May 2015

  • Quality Control - Product/ Process

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

1.1 Documentation - Should know about activity in brief

BMR preparation as per liquid injection processes PFS and Vial.
BMR preparation as per dry power injection process.
BMR preparation as per FFS Process
Manufacturing and filling process of injection
Media fill operation and documentation.
Preparation of BMR with respect to media fill activity
Compilation of data and reports
Should know about Process and TS validation
Should handle the USFDA and regulatory audits

1.2 Process Validation and Compilation

Should able to know about the Injection process validation
Should work on PASX before is more preferable
Should capable to handle all the trouble shooting during the process validation
Should part of process improvement and optimization before this
Should know about the regulatory requirement

1.3 Preparations of operational and process SOP.

1.4 Co-ordination with CFTs (i.e. Production, QA, QC) for exhibit exhibition, process validation, BMR activity and various documentation

1.5 Should independent handling of process validation of Injection.

1.6 Should know about the Product transfer activity from site to site.

Should know about the Packaging activity is more preferable

Smart & Energetic; Enthusiastic & self initiating, Should be able to manage his job responsibility independently, Should possess excellent verbal & written communication, inter-personal skill.

Competencies/Skill sets for this job

Process Validation Injection Regulatory Audits Sop Regulatory Pfs

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