Must Have Skills: CSV (Computer System Validations)
Good To Have Skills: Hands-on with pharma based applications like LIMS, LMS, DMS, SAP, TrackWise and like others.
A CSV consultant will use his/her knowledge of FDA cGMP and related regulations and guidelines, and specific knowledge of computer validation methodologies and principles to perform CSV on a variety of systems and programs.
Experience of QA in a FDA regulated environment is preferred.
At least 3-10 years of Computer System Validation or any validation experience required. Past experience writing, reviewing and executing computer validation documentation (Validation Plan, IQ, OQ, PQ, RTM, summary report).
Experience in any other validations (cleaning, process, LAB instruments, manufacturing systems and others) would be a plus.
a) Pharma Regulatory Compliance and CSV
b) Validation testing and related skills
c) Experience in V- Model and Validation life cycle of regulated projects
d) GxP Awareness including Good Documentation Practices
e) Knowledge on GAMP5 Guidelines
2. Professional Experience
a) FDA and other regulatory guidelines
b) Good problem solving and decision-making skills
c) Excellent oral and written communication skills
d) Experience in supporting external audits
3. Desired Candidate Profile
a) Education: UG -B. Tech/B.E. - Computer/B-Pharm/M-Pharm
b) Excellent communication skills.
c) Ability to work as a team player in a consulting environment.
d) Proficiency with MS Office tools and Strong Project Management experience (preferred but not required)