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vadodara, India SUN PHARMA Full timeRole : Manager / Sr.Manager Global Quality Sustainability, Training and Quality CultureFunction : Global Quality & ComplianceLocation : Mumbai / BarodaAreas of Responsibilities :Setting up baseline data for sustainability projects and Quality Cultural from various SUN sites.Assessment, interpretation and review of baseline data and support site...
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Vadodara, India SUN PHARMA Full timeRole : Manager / Sr.Manager Global Quality Sustainability, Training and Quality Culture Function : Global Quality & Compliance Location : Mumbai / Baroda Areas of Responsibilities : Setting up baseline data for sustainability projects and Quality Cultural from various SUN sites. Assessment, interpretation and review of baseline data and support site...
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vadodara, India SUN PHARMA Full timePOSITION SUMMARYDirect the Global Quality Specialized Training program, ensuring a new portfolio of training offerings are offered to the Sun Global network, in order to enhance a baseline of Quality Compliance training. (i.e. Investigator Qualifications, APQR/CPV, statistical product evaluation, 6S inspection readiness, QP forums, etc.).The incumbent will...
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Dir. Global Quality – Specialized Training
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Assistant Manager Quality Assurance- Pharma
5 months ago
Responsibilities
:
Ø Review and approval of SMF, VMP and Quality manual.
Ø Review and approval of BMR, BPR, MFC.
Ø Review and approval of OOS/OOT.
Ø Review and approval of Vendor list.
Ø Planning, execution and compliance of both internal and externalaudits.
Ø Review and approval of all Quality Assurance, quality Control and manufacturing records.
Ø Review of filled BMR/BPR and analysis data, and release of batch for dispatch.
Ø Review and approval of SOPs.
Ø To prepare audit and compliance reports and CAPA reports.
Ø Review and approval of Qualification Documents.
Ø To review and approval of Change control.
Ø Review and approval of Deviation, Incidence.
Ø Review and approval of APQR.
Ø Review and approval of Method of analysis, Specification, Stability report, Technology transfer and Modification of area.
Ø Review and approval of hold time study protocol and report.
Ø Review, approval and Implementation of CAPA.
Ø To review, assessment and closer of market complaint and product recall.
Ø Review of pest control and rodent control.
Ø Training.
Ø To handle all regulatory, FDA and cGMP audits of customer.
Ø Review the documents and data control.
Ø Review and approval of all validation documents.
Ø To review, monitor IPQA activities.
Key Skills :
Bmr Mfc Bpr Internal Audit External Audit Sops Documentation
