Posted:4 weeks ago|
Platform:
On-site
Full Time
CSV Engineer opening
================
Experience: 4-9 years
Location: Vadodara
Notice Period: 30 days max. Immediate Joiner preferred.
Key Responsibility:
In this role you would be required to work on following:
1. To ensure that all the computer system validations activities are carried out in accordance with approved procedure across multiple manufacturing locations.
2. 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.
3. To handle Pharmaceuticals QMS documents like Change Control, Deviations and Investigation & CAPA and support in closure of the incidents.
4. 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
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