Teva Pharmaceuticals Hiring Sr Mgr Quality Professional B. Pharm, / M. Pharm / M.Sc. (Science), B.S. Sciences Apply Now
Job
Description
Quality
Due-Diligence /Support in evaluation of CMO’s quality systems and compliance,
e.g. Review of CMOs quality evaluation of preliminary questionnaire,
assessment, apply internal / external intelligence to evaluate and facilitate
the site due-diligence meeting / audit etc. and provide input to the
management.
Establishment
of Quality Agreement (QTA) between Teva receiving site & CMO
Participate
as a team member when appropriate in developing CMO and getting ready for PAI
Facilitate in
transferring registration and relevant Quality document to CMO & formally
document the transfer
Annual
Product Review (APR) / Product Quality Review (PQR)
Change
Management Complaint Management
Input to
Business Review Meetings, Quality councils & Participation in SRTs
Periodic
Quality KPI & Reports of CMO Quality Oversight at CMO’s
Stability
Management CMO Batch Document review and release for distribution
Deviation /
Investigation Management Issue Management (NTM) Audit Management & Periodic
Quality Risk Assessment
Customer /
Regulatory Authorities Inspection Support to Initiatives Supplier Exit or
Change of Supply
Qualifications
Candidate
with minimum 15 years of overall experience from good pharma company
Experience
from regulated market is must – USFDA and Europe market
Person will
be responsible to coordinate with3rd party suppliers and maintain relationships
hence candidate with good convincing power and excellent communication skills
are required
Will be
working for sterile but more in OSD so experience of OSD is must
Experience
from TPO is added advantage
Education: B.
Pharm, / M. Pharm / M.Sc. (Science), B.S. Sciences
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