Sun Pharmaceutical Industries Ltd
Designation : Senior Manager
Function : QA
Functional Area : Analytical (QC) QA
Job Role Summary : Manage overall batch certification review of QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, instrument preventive maintenance/calibration/qualification/validation as per good manufacturing practices/good documentation requirements and ALCOA++ principles).
Job Profile :
- Lead the review of all QC records related to Batch certification program.
- Review Deviations, CAPAs, OOS/OOT investigations.
- Ensure that all activities are compliant with Standard Operating Procedure, STP and GP etc.
- Review initiated CAPA records related to QC investigations for completeness and adequacy.
- Review and approval of qualification, analytical method transfer, validation protocol and reports for accuracy, completeness and traceability as well as adherence to the Protocol/procedures.
- Training of QC and QA teams.
- Work in partnership with Quality Control and Quality Assurance.
- Follow the EHS policy, laboratory procedures and maintain the compliance to cGMP requirements.
Job Requirements :
- Â 15 to 17 Yrs
- QV Documentation and Document review
- Experise in GMP, QC / QA Requirements, Data Integrity Requirements, Instruments and Audit trails
Work / Job Experience : 15-17 Years
Type of Experience : QA, Analytical QA, Quality Control, QC Documentation
Academic Qualifications :
B.Pharm / M.Pharm
