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:
- Lead inspection process in the plant
- Coordinate with external parties/ internal CFT/ Quality Head and Site Head to organize regulatory inspections/ customer/ certification body audits at site.
- Will be responsible to update Senior Management on the audit process and outcome on a timely basis as per SOP
- Will be responsible for timely response to the observations generated from the inspection, initiation of CAPAs in order to address the observations, follow-up with the responsible person/ department for completion of the actions within due date, review of CAPA/ action item closure for adequacy and involve in effectiveness check
- Frequent shop-floor visit in order to verify the compliance status, identifying and highlighting possibilities of repeat observation and potential noncompliance that can lead to observation during inspections
- 483 observations/ other inspectional observations- perform gap assessment and implement CAPA in case of any gaps.
- Lead Internal audit/ Self Inspection
- Ensure effective self-inspection process is in place to proactively detect potential compliance risk and mitigate through effective CAPA.
- Plan, coordinate and ensure compliance.
- Driving system and facility improvements based on the gaps identified during self-inspection.
- Supplier Management
- Responsible for qualification of suppliers related to API/RM/PM
- Responsible for qualification of suppliers for critical consumables and items used in aseptic areas.
- Responsible for qualification of other service providors
- Coordinate for risk assessments in case of any noncompliance observed with respect to suppliers
- Global Actions/ CAPAs
- Coordinate with Global Quality Management with respect to assessment and remediation of the gaps identified in other facilities of Sun or other organizations.
- Others: Training of team members in order to enable them to perform their jobs in proper way.
