Manager- CAPA Effectiveness

Job Description

Job Description Position: Manager: CAPA Effectiveness Job Title: Manager: CAPA Effectiveness Job Grade: G10 Function: Global Quality and Compliance Sub-function: Corporate Quality Audit Manager s Job Title: Lead - CAPA Effectiveness Skip Level Manager s Title: Function Head Title: Location: Tandalja (Baroda R&D) No. of Direct Reports (if any) Job Summary Areas of Responsibility To conduct the CAPA effectiveness review activities at manufacturing sites of Sun Pharma as per the review plan To perform CAPA effectiveness review for CAPAs provided to Regulatory Authorities. To perform review of implementation status of Global CAPA across Sun manufacturing sites. To inform CAPA effectiveness review outcome to Lead / HOD and prepare CAPA effectiveness review report within stipulated timeline. Participate in Regulatory Audit Review activities of manufacturing sites of Sun Pharma, need basis. Sound knowledge of current regulatory requirements/expectations Effective interpersonal, communication and organizational skill Participate and support project work as allocated by reporting authority Travel Estimate Job Scope Internal Interactions (within the organization) External Interactions (outside the organization) Geographical Scope Financial Accountability (cost/revenue with exclusive authority) Job Requirements Educational Qualification B. Pharma or M. Pharma Specific Certification Skills QA Background, Knowledge of QMS or Compliance, US FDA experience is require. OSD and Sterile experience is require - sterile will be preferable Experience 10 to 16 years of work experience. Experience in a pharmaceutical organization with good exposure of Quality and Manufacturing Operations. A strong knowledge of GMP s and regulatory audits, CAPA assessments in international regulatory environments. Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).