Life Sciences : CAPA Manager : PV : Mumbai : Apply Now

Job Description

Job Description: Active involvement in CAPA management activities within the team. Preferably must have faced Internal /Client audit. Working knowledge of the global pharmaceutical/pharmacovigilance regulations (ICH/ Good Pharmacovigilance modules) is preferable. Knowledge of TrackWise shall be an added advantage. Interpersonal and professional skills to interact at all levels including senior executives, contractors, and colleagues. Contribute to Global PV CAPA & Deviation Management implementation and documentation by completing all required processes as assigned. Audit & Inspection CAPA Management: 1. Collaborate with company departments/teams internal and external to provide oversight and ensure proper development of CAPAs from internal quality audits and support regulatory inspections, as assigned by respective stakeholders. 2. Support the Company Main Contact (CMC) responsible for the development of responses to Audit, Regulatory Inspection or Process Deviation observations. 3. Set up and coordinate the required meetings on behalf of the CMC in order to expedite the CAPA preparation and closure process. 4. Perform the role of Assigned to Finding Owner within the eQCMS in order to support the CMC and Assigned to CAPA Owner. 5. Ensure timely and effective closure of assigned Global PV CAPAs in collaboration with the CMC, Finding and CAPA Owners. 6. Contribute to Global PV CAPA Management implementation and documentation by completing all required processes - Obtain evidence of CAPA completion. Track and monitor CAPAs with assigned stakeholders. Ensure CAPA effectiveness checks, where applicable. Deviation Management: Support the Department Manager/ Designee in planning, executing and managing deviation and its associated CAPAs through eQCMS; monitor due dates and related extensions. Set up & coordinate the required meetings with concerned Otsuka stakeholders in order to expedite creation of Deviation & its related CAPAs. Collaborate with Department Manager/Designee regarding deviation related activities, including eQCMS access. Coordinate and manage effective entry/ follow ups of PV related deviations. Support the Department manager/ Designee in reviewing the deviations and its related CAPAs. Perform the role of Originator &/or Assigned To within eQCMS. Ensure timely & effective closure of deviations & its associated CAPAs. Contribute to Global PV Deviations Management implementation and documentation by completing all required processes - Obtain evidence for Deviation completion. Track and monitor Deviations and its associated CAPAs with assigned stakeholders. Ensure CAPA effectiveness checks, where applicable. Utilize company systems as provided access/training to, including but not limited to, the following: eQCMS (i.e. TrackWise etc.) SOP system(s) SharePoint Communications (e.g. Outlook, Teams).