Executive - QC

Job Title:

Executive / Sr. Executive

Business Unit:

Sun Global Operations

Job Grade

G12A

Location :

Halol

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:

1.   Review  and approval  the QMS  e.g  OOS ,OOT, Lab event , deviations ,change control ,CAPA  etc.
2. Review /Approval   the routine  analytical raw data  of finished products /API  /IP/PV/Pkg etc.
3. 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.

1.       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.

1. Facilitate internal and regulatory agency audits, ensuring that findings from site audits are

            understood, assessed and addressed site wide in a comprehensive manner.

1. Monitor industry trends/issues faced internally and identify scope for improving Site quality

            assurance management and processes. 

1. 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.

1. To ensure the compliance on control and maintenance of Quality Control system this includes 

   daily round and observations.

1. To be a team member in identification of RCA and CAPA.
2.    Review and approval of QA of QC and respective department SOP in EDMS Software.
3.    To ensure the response provided by QC is adequate and compliance for the observation 

   Findings in Quality Control.

1.    To review and approval of OOS investigation report/Out of trend investigation report/Out of 

   Calibration report/ Laboratory Event/ Deviation/ Action item/ CAPA.

1.    To approve analytical COA & test plan in LIMS.
2.    Responsible to review Audit trail of laboratory instruments and software like EWS, Empower, LabX                etc.
3. To release/Approval of the RM/PM in SAP HANA and Analytical technology transfer/validation /development etc.
4. Responsible to provide a data of OOS/OOT/Lab Event/FAR/OOC/CAPA/Recall for Quality Council/ R&D Team as applicable.
5. Responsible to provide analytical data for annual quality review as applicable.
6. Responsible for verification of qualification and training record of Laboratory Analysts.
7. Trending of QA observations from raw data review and suggest for improvement.                                                                                                                                             
8. Approval of stability protocol, Method Transfer protocol/report, Method Validation Protocol / report, stability summary report.
9. To review Pharmacopeia – Evaluation and Equivalence Report.
10. 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.
11. To actively participate in cross functional investigation.
12. Review of regulatory query response.
13. To provide technical training with respect laboratory function.
14. Issuance of template/documents /log books etc.</