Senior Manager – Compliance

• 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.

• Ovearall experience of atleast 15 to 16 Yrs and >3 years of experience as Compliance Lead/ QMS Lead

B.Pharm / M.Pharm / MSc