Easter Seals Jobs

Job Responsibility:

1. Responsible to ensure GxP Computerized Systems at Mohali site are in compliance with the current regulatory standards. (Computerized systems include Firmware based device, embedded systems, Process Control Systems- HMI/IPC, PLC/SCADA & Spreadsheet etc.).

2. Ensure implementation of relevant quality policies, standards and procedures for computerized systems.

3. Act as QA-lead for Validation of computerized system and participate in internal audits and review of audit trails.

4. To Review & Approve Periodic Review reports for accuracy and ensure key documentation of computerized systems consistently meets the required quality standards throughout its lifecycle

5. Verification of CAPA related to IT System.

6. Review and Approve validation deliverables (SOPs related to IT System) and lifecycle documentation for computerized systems Review.

7. Ensure the availability of the site CSVMP as per the quality procedure.

8. Ensure the availability of inventory of computerized systems and infrastructure, ensure its compliance status.

9. Ensure the periodic activities as per the quality procedures are performed in a timely manner.

10. Provide support in the education and training of personnel in relevant areas of compliance and validation for computerized systems.

11. Work in partnership with the site cross functions and corporate functions for Audit readiness of computerized systems (for Validation and lifecycle management) for all internal/external and regulatory inspections.

12. Review and approval of QMS (Deviations, Change Control, CAPA, incidences, investigations &SOPs tc.) Related to computerized systems.

13. Ensure resolution of identified risks/gaps related to computerized systems in a timely manner.

14. Mentoring and supporting site cross functions to resolve issues related to computerized systems.

15. Perform assessment /audit of suppliers / vendors of site computerized systems.

16. Perform the GxP computerized systems assessment and support remediation for ensuring 21 CFR parts 11, EU Annex 11 readiness, adequate security and controls.

17. Draft response and comply internal/ external audit observations for computerized systems.

18. Lead the assessment, tracking of remediation and monitoring of identified actions as part of various corporate initiatives.

19. Lead to present/discuss and define way forward for fast track remediation of open action items related to computerized systems in site QRB meetings.

20. Perform other duties as assigned by Functional Head time to time.

21. To participate in the investigation for deficiencies and ensuring closure through adequate impact analysis/ corrective action or justification.

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.