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.”
Position Summary –
- Ensure compliance of cGMP and safety standards in laboratory.
- Ensure timely completion of periodic calibration, performance verification, preventive maintenance and qualification of instruments.
- Ensure timely closure of instrument breakdowns.
- Initiation and approval of change control, lab event, deviation, OOS, OOT & CAPA etc.in trackwise.
- Provide monthly metrics data as per management requirements.
- To review/approval of calibration calendar and calibration master list of instrument/devices and compliance of monthly and yearly calendar.
- AMC of instrument and external calibrations.
- Support in timely backup of all computer related software used in laboratory.
- Responsible for laboratory investigation and root cause analysis of OOS, OOT, Deviation and its characterization and accordingly implementation of appropriate CAPA.
- Manage resource planning of (log books, chemicals, glassware, chromatographic columns and laboratory standards).
- Ensure the availability, usage, storage and qualification (if applicable) of laboratory standards, chemicals and chromatographic columns.
- Support in up gradation and installations of software being used in laboratory as per cGMP requirement.
- Participate in all internal, external and regulatory inspection at site.
- To follow and ensure compliance to EHS standard in laboratory.
- Review and Approval of qualification and calibration records.
- Raise Capex proposals and ensure the capitalization of the budgeted items as per requirements.
- Assure all time readiness of site for regulatory agency inspections/ internal audits and appropriate implementation of corrective actions regarding observation made by the agencies/ internal audit teams.
- GRN approval in SAP and other transactions as per requirement.
- Approval of purchase request coordination with purchase team and associated vendors to support QC operations.
- Responsible for effective managing the change control and quality risk management process at site & ensuring all requirements of the process are adhered to and providing approvals.
