At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Key responsibilities:
- Review and approval the QMS e.g OOS ,OOT, Lab event , deviations ,change control ,CAPA etc.
- Review /Approval the routine analytical raw data of finished products /API /IP/PV/Pkg etc.
- Assure all time readiness of site for regulatory agency inspections\internal audits and
appropriate implementation of corrective actions regarding observations made by the
agencies\internal audit teams.
- Ensuring compliance to regulatory requirements on product, process and
release procedures. Ensure release of safe and effective drug products from site as per cGMP
Requirement and regulatory commitment.
- Facilitate internal and regulatory agency audits, ensuring that findings from site audits are
understood, assessed and addressed site wide in a comprehensive manner.
- Monitor industry trends/issues faced internally and identify scope for improving Site quality
assurance management and processes.
- Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and
Diligence. Performs all work in accordance with all established regulatory and compliance and
safety requirements.
- To ensure the compliance on control and maintenance of Quality Control system this includes
daily round and observations.
- To be a team member in identification of RCA and CAPA.
- Review and approval of QA of QC and respective department SOP in EDMS Software.
- To ensure the response provided by QC is adequate and compliance for the observation
Findings in Quality Control.
- To review and approval of OOS investigation report/Out of trend investigation report/Out of
Calibration report/ Laboratory Event/ Deviation/ Action item/ CAPA.
- To approve analytical COA & test plan in LIMS.
- Responsible to review Audit trail of laboratory instruments and software like EWS, Empower, LabX etc.
- To release/Approval of the RM/PM in SAP HANA and Analytical technology transfer/validation /development etc.
- Responsible to provide a data of OOS/OOT/Lab Event/FAR/OOC/CAPA/Recall for Quality Council/ R&D Team as applicable.
- Responsible to provide analytical data for annual quality review as applicable.
- Responsible for verification of qualification and training record of Laboratory Analysts.
- Trending of QA observations from raw data review and suggest for improvement.
- Approval of stability protocol, Method Transfer protocol/report, Method Validation Protocol / report, stability summary report.
- To review Pharmacopeia – Evaluation and Equivalence Report.
- To perform the trend analysis of OOS/OOT/Lab Event/QA of QC observation and evaluate the CAPA effectiveness for repetitive Deviation and internal quality observations.
- To actively participate in cross functional investigation.
- Review of regulatory query response.
- To provide technical training with respect laboratory function.
- Issuance of template/documents /log books etc.
- Verification of data associated with qualification of laboratory instrument.
- Verification of data associated with the sample destruction
- To issue, review, maintain & archive GMP documents for QC lab.
- Perform the internal audit.
- Review and approval of Raw material and stability summary sheet report.
- Lead to present/discuss and define way forward for fast track remediation of open action items related to computerized systems in site Global review meetings.
