Position: Manager 1- Quality Metrics Management & Trackwise Enhancements

　　Department: Corporate Quality and Compliance Location: India (SPIL, Tandalja)

　　Job Summary:

　　Responsible for all aspects of Quality Metrics programs across all SUN Pharma Globally. Provide overall Quality metrics parameters strategic direction for all compliance activities, consistent with Quality system, Product Quality and objectives.

　　Act as a champion for building a Quality metrics across the organization. Proactive assess compliance issues and risks in all operational areas for the Company, providing strong leadership and expertise and setting and maintaining compliance standards throughout the Companys complete value chain.

　　Additionally, responsible to assess Trackwise enhancements and implement across sites in compliance manner.

　　Essential Job Functions:

　　Quality Metrics Management

　　Simplify Quality Metrics parameters based on Sun Pharma internal requirement, ISPE, PDA & FDA guidance.

　　Set the Quality Metrics parameters calculations and definitions in line with current regulatory expectation and/or internal requirements and ensure uniform implementation across sites.

　　Prepare/Review Quality Metrics Definition and Calculation document for applicable Quality Metrics parameters

　　Design Quality Metrics Monthly Report template based on definition and calculation document.

　　Prepare/Review Quality Metrics Guidance document for applicable parameters

　　Ensure that Quality Metrics parameters and definitions are in line with FDA requirement, as applicable.

　　Set the Quality Metrics parameters calculations and definitions in line with current regulatory expectation and/or internal requirements and ensure uniform implementation across sites.

　　Co-ordinate with sites to ensure that the Quality Metrics Monthly Reports data is available on-time for compilation.

　　Prepare/Review Monthly / Annual Global Quality and Compliance Report of key Quality Metrics parameters.

　　Review and analyzed key Quality Metrics parameters, perform trending and present in the Global Quality and Compliance Monthly Report.

　　Pro-actively evaluate the compliance risk based on quality metrics data and work with sites towards improvement. Also, identify a typical trend and communicate in the Global Quality and Compliance Monthly Report.

　　Compile Quality Metrics data (For applicable parameters) and support to prepare presentation in accordance to the management requirements.

　　Maintain database for Quality Metrics Parameters and update on monthly basis.

　　Prepare Monthly report for Metrics Management Function in adequate manner on monthly basis.

　　Trackwise Enhancement

　　Receipt, Logging, Assessment and Implement all enhancement requests received from TW users.

　　Work with Technical owner (IT) on required enhancements for technical feasibility and plan to implement required enhancement on timely manner.

　　Co-ordinate with stake holders like Corporate Quality Policy & Training group along with sites TW SPOCs to ensure revision of impacted document on time prior to change is effective.

　　Adequately review of Changes and Deviation/Incident associated with TW system

　　Participate in validation from business side which includes review of qualification scripts; execution of PQ scripts etc. but not limited to.

　　Pro-actively communicate end users for the changes related to TW enhancement and impart Training on workflows, if needed.

　　Identify the need for crystal report which can facilitate better and harmonized trending. Work with IT to ensure reports are developed as per business requirements.

　　Download Trackwise Crystal Summary Report for QMS parameters on monthly basis

　　Prepare Monthly report for Trackwise Enhancement Function in adequate manner on monthly basis.

　　Perform all other duties assigned to achieve outcomes.

　　Perform all work in accordance with established regulatory and compliance and safety requirements.

　　We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.