10 Aug
|
Sun Pharmaceutical
|
India
10 Aug
Sun Pharmaceutical
India
Job Title:
Sr. Manager (Compliance Lead)
Business Unit:
Sun Global Operations
Job Grade
G9A
Location :
Baska
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 team-oriented spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Key responsibilities:
- Lead inspection process in the plant
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- 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
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- 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
- Responsib
📌 Senior Manager (India)
🏢 Sun Pharmaceutical
📍 India