Silvassa
21 hours ago
JOB ID:164263
Job Type
Full Time
Functional Area
QA/Testing
Industry
Pharma/Biotech/Clinical Research
Education
Not Specified
Experience Required
8 - 10 Yrs
Key Skills Required
review investigations, qms
Other Skills Required
Job Description
POSITION 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).
The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’ s and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma policies and procedures.
Key responsibilities:
1. Lead the review of all QC records related to Batch certification program.
2. Review Deviations, CAPAs, OOS/OOT investigations,
3. Ensure that all activities are compliant with Standard Operating Procedure, STP and GP etc.
4. Review initiated CAPA records related to QC investigations for completeness and adequacy.
5. Review and approval ... See More
POSITION 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).
The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’ s and applicable department programs, including training, documentation, standard operating procedures, and Sun Pharma policies and procedures.
Key responsibilities:
1. Lead the review of all QC records related to Batch certification program.
2. Review Deviations, CAPAs, OOS/OOT investigations,
3. Ensure that all activities are compliant with Standard Operating Procedure, STP and GP etc.
4. Review initiated CAPA records related to QC investigations for completeness and adequacy.
5. 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.
6. Training of QC and QA teams.
7. Work in partnership with Quality Control and Quality Assurance
8. Follow the EHS policy, laboratory procedures and maintain the compliance to cGMP requirements
Location: Dadra
Educational Qualification B.Pharm / M.Pharm
Experience 8 to 10 Years of experience See Less
Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 5.1 billion. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe.
