Sr.manager Qa It- Csv

Job Title Sr Manager QA IT- CSV Business Unit Global Quality Compliance Job Grade G9B Location Pithampur Indore Greenfield 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 Summary The QAIT person is responsible for ensuring that the GxP Computerized systems complies with regulatory requirements through Computer System Validation CSV This role supports CS implementation validation and maintenance in alignment with internal QMS and regulatory requirements Key responsibilities To lead and support CSV activities for GxP systems including planning execution and documentation Ability to manage validation timelines coordinate with stakeholders and handle documentation workflows Manage and support for Validation of GxP Applications i e new system implementation or upgrade of existing applications in Manufacturing Production System Enterprise Systems to comply with regulatory guidelines Support for implementing the global Quality-IT initiatives at sites To ensure compliance of all GxP computerized systems as per internal QMS and regulatory requirements Ensure key documentation of computerized systems consistently meets required quality standards throughout its lifecycle Providing expertise during software development lifecycle to assure that validation of GxP IT computerize systems is planned and executed for user requirements and intended use Author validation plan for projects along with the review of validation qualification deliverables of the assigned GxP IT systems in line with organization procedures and regulatory expectations Perform vendors audits of new Vendor as well as of existing Vendors as required to ensure vendor s Quality Systems are effective and meet regulatory standards Supporting IT Infrastructure qualification to comply with regulatory guideline Ensure quality processes and standards are aligned through project rollout Support projects for simplification and productivity enhancement initiatives Perform GxP computerized systems assessment referring requirement of 21 CFR part 11 EU Annex 11 applicable regulatory standards and internal procedures Ensure remediation of identified gaps for systems compliance in timely manner with the support of cross functional team for continuous improvements Responsible to comply an internal external audit observation Mentor and provide support in the education and training of personnel in relevant areas of compliance and validation for GxP IT systems Support the sites Computerized System for evaluating QMS wherever required and providing guidance and support in closure of the same Perform periodic validation reviews of the GxP application system along with the relevant stakeholders Knowledge of Computer Software Assurance CSA requirements Travel Estimate Job Requirements Educational Qualification M Sc B Pharm B E Experience Skills Skills Hands-on experience with validation of GxP Computerized Systems Strong understanding of GAMP 5 validation lifecycle and documentation IQ OQ PQ Knowledge of FDA 21 CFR Part 11 EU Annex 11 and data integrity principle Experience 15 to 17 Yrs 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