Manager - 2 Corporate Quality IT- CSV

Sun Pharmaceutical Industries View all jobs

  • Halol, Gujarat
  • Permanent
  • Full-time
  • 16 days ago
Position:Manager/ Sr. Executive/Job Title:Manager/ Sr. Executive Corporate Quality IT- CSVJob Grade:G11A/G11BFunction:CQ ITSub-function:CQ IT ComplianceManager's Job Title:DGMSkip Level Manager's Title:NAFunction Head Title:Sr. General ManagerLocation:Vadodara (Halol and Baska)No. of Direct Reports (if any)NilJob SummaryAt 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.”The MES CSV Executive is responsible for ensuring that the Manufacturing Execution System (MES) complies with regulatory requirements through Computer System Validation (CSV).This role supports MES implementation, validation, and maintenance in alignment with internal QMS and regulatory requirements.Areas of Responsibility
  • To lead and support CSV activities for MES 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
  • Support sites before and during the regulatory audits.
  • Support sites 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 EstimateFrequent travel required, Approx. 50%Job ScopeInternal Interactions (within the organization)With all sites (IT, QA and IT QA)External Interactions (outside the organization)With Vendors related to CSV and OEMGeographical ScopeMumbai/VadodaraFinancial Accountability (cost/revenue with exclusive authority)Job RequirementsEducational QualificationB. Pharm/M.Sc./B.ESpecific CertificationNilSkillsHands-on experience with validation of MES platforms like Werum PAS-X, Rockwell or similar.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 principleExperience7 Years-9 YearsDisclaimer: 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).

Sun Pharmaceutical Industries