CNC Validation Analyst - Warsaw, IN
Apply NowCompany: Georgia IT, Inc.
Location: Warsaw, IN 46580
Description:
Job Title : CNC Validation Analyst
Location : Warsaw, IN
Salary : DOE (salary Plus benefits)
Position Type : Fulltime
Interview : Phone
(US Citizens, Green Card and GC-EAD Preferred)
No sponsorship available for this job, direct hire and NO 1099 or C2C
Technical/Functional Skills
Location : Warsaw, IN
Salary : DOE (salary Plus benefits)
Position Type : Fulltime
Interview : Phone
(US Citizens, Green Card and GC-EAD Preferred)
No sponsorship available for this job, direct hire and NO 1099 or C2C
Technical/Functional Skills
- 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.