Senior Manager – Quality e-Compliance

1 week ago

Medak India Piramal Enterprises Full time

Job Description Job Description : 1. Ensuring that computer system validation deliverables like GXP, Software categorization, software qualifications, configuration specification, Risk assessment, negative challenging tests, backup & restore procedure, validation summary report, requirement traceability matrix and 21 CFR part 11 requirements are available for all the GxP systems 2. To revisit the site specific SOP's related to IT and ITC periodically to in line with the corporate IT guidelines/current regulatory standards and to maintain the work practices is in line with the current SOP's. 3. Preparation and Execution of the IT Roadmap for the site. 4. Facing Regulatory and customer audits and presenting the IT compliance status with the support from the respective SME. 5. Evaluating, reviewing the IT observations, internally, or during the audits, and supporting the respective department in identifying effective CAPA. 6. To perform IT supplier assessment for GAMP3, GAMP4 or GAMP5, software before procuring. 7. Perform adequate investigation and providing the root cause for the deviations identified during the failures/Deviations of computerized systems. 8. To ensure that all the computerized systems are meeting the 21 CFR part 11 and electronic signatures/records requirements. 9. To review and approve of all the validation/qualification documents related to computerized systems and ensuring the documents are in compliance. 10. To ensure that all IT related Risk assessments are made and necessary Risk mitigations are executed 11. Providing the sufficient training to the site team and ensuring that all the IT team members are become experts in their job role. 12. Report any incident/accident/ near miss/ illness to the superiors 13. Identify unsafe conditions and unsafe acts and report to superiors.

  • Senior Manager – Quality e-Compliance

    1 week ago

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    Ensuring that computer system validation deliverables like GXP, Software categorization, software qualifications, configuration specification, Risk assessment, negative challenging tests, backup & restore procedure, validation summary report, requirement traceability matrix and CFR part requirements are available for all the GxP systems To revisit the site...

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