Company: Avanteva Solution
Job Title: PLC Validation Engineer- (Both CSV & PLC must)
Candidate must have experience in developing and
implementing the CSV framework at Organizational
level meeting the regulatory requirements.
Candidate must have in-depth knowledge of regulatory. guidelines for CSV as well as PLC Validation (Both must) i.e. 21CFR Part 11 ERES, Part 820, Part 210 & 211, EU Annex 11, ICHQ9.
Managing Gap Analysis & Risk Assessment. Candidate should have strong exposure in Information Technology and IT Quality of Computer Systems/ Software Validations.
Candidate should have experience on assessment and remediation of computerized systems for Electronic Record & Electronic Signature (ER/ES) compliance including data security, traceability, and integrity. Candidate should have a good understanding of GAMP 5 and have hands-on experience in Computer Systems Validation (CSV) using V-Model, CSV of Cloud computing in a pharmaceutical environment. Must have experience of leading the CSV operations for enterprise application and Standalone instrument/ equipment’s.
Candidate who comply with the above skills, please feel free to write us to email@example.com