Position: CNC / Software Validation Analyst
Location: Warsaw, IN
Duration: Full Time
- At least 5 – 7 years’ hands-on experience in Software Validation in the Pharmaceutical and/or Medical Devices industries.
- Strong understanding of CNC software Validation
- Experience with validation of manufacturing shop floor applications
- Experience in authoring/executing Validation Master Plan, Risk Assessment/GxP assessment ,VP, URS, TM, IQ,OQ,PQ protocols, Final Validation Report.
- Experience in process validation.
- Excellent Communication skills is a must
- Ensuring that process followed fully comply with regulatory requirements, company policies and procedures
- Actively maintain the Inventory of existing applications, conducting CSV determination assessment and risk assessment and mentor the team for the same.
- Manage the execution of remediation procedure for the inventoried systems
- Ability to work with teams based at onsite and offshore and achieve project objectives
- Experienced and guiding software validation team in creating quality documents adhering to GAMP5 and 21 CFR 820 requirements
- Demonstrated ability to learn new areas and apply Validation principles
- Strong Experience in GAMP4/GAMP5 based validation
- Experience in validating systems against 21 CFR Part 11