Manager - 2 Fresher's job

Job Responsibilities : Manager Quality Control

1. Analytical Testing: Management of timely testing (Related to GC and GC-MS Lab) and release of all API’s, Intermediates, In-process material and Finish products as per approved Specification, STP and customer requirement.
2. Review of Analytical Record: To establish and control a system for review of laboratory records before release of API’s, Intermediates, Raw Materials and Recovered Solvent.
3. CQMS (Trackwise): To initiate/review and approval of records in CQMS. To perform preliminary laboratory investigation after reporting of OOS / OOT / Lab event in a batch within timeframe. To identify root cause and initiate corrective and preventive (CAPA) actions and to ensure compliance to GMP requirement. To perform investigation in QC laboratory for all deviations reported to find out the root cause and implementation of CAPA and to ensure CAPA effectiveness.
4. Review and approval of protocol and report related to manufacturing, instrument qualification, method validation /transfer etc.
5. Resources: To plan Resources as per approved budgets, equipment usage, instruments, facilities, reagents, spares and instrument maintenance and to accomplish production requirements.
6. Analytical Method Transfer: To ensure all Analytical method are transferred to laboratory as per protocols, current requirements and overall compliance as per SOP. To ensure Method Transfer activity is performed as per current requirements.
7. Internal/external inspection: To participate in external and/or regulatory inspections of QC operations at the site.
8. Sample Handling: To ensure under test samples are properly handled and stored in laboratory and ensure disposal of samples are completion of analysis and review of analytical record.
9. SOPs/Specifications/STPs: To review and approval/rejection of Standard Operating Procedures/Specification and test procedure for respective area in DCM/EDMS application system.

1. Involvement in new project related activities. To ensure the proper Implementation of LIMS. To ensure the complete data migration from DCM to LIMS.

1. Training:

• To ensure continuously up-gradation of skills and knowledge through training and technical inputs of staff
• To ensure that analysts are qualified for the job.
• To ensure consistency in lab operations and drive continuous improvements in laboratory performance.
• To impart training (Regulatory/cGXP, Sun-Pharma specific, Activity based SOPs and Development) as per requirement.

Safety: To ensure compliance to cGMP and applicable safety standards in the QC laboratory Management of QC personnel.

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Sun Pharmaceutical Industries Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients in more than 100 countries across the globe.