Key Responsibility:
In this role you would be required to work on following:
To ensure that all the computer system validations activities are carried out in accordance with approved procedure across multiple manufacturing locations.
To provide input to validation planning for projects; along with the review of validation/qualification deliverables of the assigned project/system in line with the organizational SOPs and adhering to company procedures and regulatory expectations.
To handle Pharmaceuticals QMS documents like Change Control, Deviations and Investigation & CAPA and support in closure of the incidents.
To review and approve all recommendations points for gap & Risk assessments based on regulations.
Requirements:
Good understanding of GAMP-5, Annex 11, 21 CFR Part 11, PIC/S and other regulatory guidelines
Understanding of the Lab and manufacturing system.
Well versed in handling Regulatory audits
Strong stake holder management skills
Qualification:
Graduate in Computer Science/ Computer Application/ any stream with intensive knowledge of Computer system validation.
7-10 years hands on experience of Computer system validation in life science domain.
Druva delivers data protection and management for the cloud era. Druva Cloud Platform is built on AWS and offered as-a-Service;...
Apply For This JobTicket logging for all the issues and requests received Log tickets with correct priority and category Assign tickets to correct...
Apply For This JobCENITPRO is looking for Operations Executive who can manage day-to-day IT operations, our ideal candidate has experience of various aspects...
Apply For This JobJob Description candidates who are interested in learning and implementing computer hardware and servicing line. The job is specified to...
Apply For This JobJob Position: – Technical Project Manager Experience: – Minimum 5 years required Salary: –75,000-90,000 per month Job Type: – Full-time/Work...
Apply For This JobShould be taking care of Entire IT Infrastructure Activities. Well Knowledge in Networking (Switching, Routing, and Commanding). Maintain IT Asset...
Apply For This Job