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

• 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 inspectionsinternal audits and
  
  

appropriate implementation of corrective actions regarding observations made by the

agenciesinternal 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.
  
  

Travel Estimate

Job Requirements

Educational Qualification

M. Pharmacy /B. Pharma , M,Sc chemistry

Experience

10+ years

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).