Teva Pharmaceuticals Hiring Quality Analyst III B. Pharm, / M. Pharm / M.Sc. (Science), B.S.
Sciences Apply Now
Job Description
Job Purpose is To manage the TPO Quality system requirements in
accordance with Teva quality standards and in compliance with the regulatory
requirements
Batch record review and disposition in global system like SAP etc.
Responsible to follow the Quality Management System of TPO
organization, which is relevant to the job function
Provide impact assessment and risk assessment for impacted CMOs, to
the Regional NTM Coordinator for the GNTMs issued, after coordinating with all
CMOs
Batch record Review &
Release
Generation of the Trackwise reports for deviations and change
controls required for batch release. Review and ensure that there are no open
deviations and change controls impacting the release of the batches.
Review of the temperature reports down loaded from temperature
recorders.
If unsatisfactory result / temperature excursion forward to the
investigation team for logging the deviation in the Trackwise and ensure
completion before release.
Change Controls : Life cycle management of change control in Global
Trackwise system
Initiate change controls related to the batch manufacturing and
packing records specifications and
analytical method of analysis stability
protocols that are received from the
CMOs
Evaluate the change controls for adequacy and perform line by line
review of the documents QC SME for change controls that need analytical
evaluation.
Review the method validation/verifications and method transfer
reports associated with the change
Review process validation/qualification and other associated
supporting documents required with the change
Experience Required : Minimum 6 - 8 years of experience in
pharmaceutical industry ,Knowledge of cGMP, Quality management Systems and the
pharmaceutical manufacturing supply
chain environment . Knowledge on Compliance Standards and Regulation as
applicable to the market , Experience of handling Operational Quality QA/QC
exposure and External / Contract manufacturing site
Experience Preferred : Knowledge and working experience with USFDA /
EU and other competent authority approved sites
Qualifications
B. Pharm, / M. Pharm / M.Sc. (Science), B.S. Sciences.
TO APPLY CLICK HERE
FOR MORE JOB UPDATES
No comments:
Post a Comment