Xzed Skills Private Limited

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 Please send your profile to [HIDDEN TEXT]