Senior Manager

Title Seniorr Manager-II - Corporate Quality Projects Business Unit Quality Job Grade G9B Senior Manager Location Baroda Gujarat Key Responsibilities 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 collaborative spirit knowing that we Thrive together and support each other s journeys Job Profile Project Lead is responsible for To have good experience exposure of LIMS System implementations Project developments support validation enhancements implementations across various site To ensure the dynamics of computerized systems w r t regulatory standards 21 CFR part 11 EU Annexure 11 GAMP 5 To have good experience exposure of SAP-HANA system well aware of SAP system functionality To have very good experience expertise of Quality Control Systems process Functional expertise on sample management Stability programme To have very good experience expertise of Quality Assurance process Specially knowledge of APQR preparation Handle control sample management To have knowledge of Quality control instruments handlings like HPLC GC UV for Sample Managements Testing Test Calculations as per pharmacopeia general chapters Monographs good understanding of Test different-different scenarios like Dissolution CU for fate value check Pass fail To provide guidance Support sites for all the major regulatory audits by Remotely Onsite visit Evaluation assessments of different business requirements received it s impact assessments and decision for its consideration for digitization simplification automations To identify the roadblocks and ensure the smooth execution of assigned projects Responsible to ensure smooth functioning of the team operations and routine activities Encouraged and developed the subordinates to explore their capabilities and take challenge to grow further To identify the actionable and accomplish the project milestone To prepare and review CSAP qualifications scripts and ensure execution of qualification To prepare ensure and support for the preparation of database and design as per compliance requirements and functional needs To ensure technical training support for each site whenever required To ensure successful handover of projects to Site Sites support site SME s for Stabilization of projects at sites To conceptualize and frame a consolidated approach for new identified technique To ensure vendor support for technical discussion on finalize of projects To perform the activities as per the project plan assigned scheduler To execute support other Quality project initiated for simplification harmonization and productivity enhancement To work in collaboration with IT API SGO vendor Site Quality and different teams for identification of the right solution tool Vendor to resolve the Specific problem and have correct solution for the organization Basic Expectation Candidate should - Have a balance of technical knowledge managerial skills - Be able to prioritize multi -task - Be able to work independently with limited supervision - Manage stakeholders get work done - Be able to create project plans Charters which is efficient from a time cost effort perspective while understanding at the long term impact of decisions Analytical Report Creation Skills - Proficiency in Excel Word PowerPoint Basic understanding of MySQL Oracle database Travel Estimate Low Job Requirements Educational Qualification M Sc B Pharma M Pharma Experience 17-22 years Your Success Matters to Us At Sun Pharma your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth Join us at Sun Pharma where every day is an opportunity to grow collaborate and make a lasting impact Let s create a brighter future together 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