CNC / Software Validation Analyst - Warsaw, IN - Georgia IT Inc.
Warsaw, IN
About the Job
Job Title : CNC / Software Validation Analyst
Location : Warsaw, IN
Position Type : Full Time
Salary + benefits
US Citizen, Green Card and GC EAD only.
No sponsorship available for this job, direct hire (No corp. to corp. or 1099)
Job Description:
Location : Warsaw, IN
Position Type : Full Time
Salary + benefits
US Citizen, Green Card and GC EAD only.
No sponsorship available for this job, direct hire (No corp. to corp. or 1099)
Job Description:
- 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 followedfully 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.
Source : Georgia IT Inc.
