Hi,
Please find the below JD and let me know if you have any suitable profiles. This is very urgent requirement *Position: **Validation Lead* *Location: **Lexington, MA* *Duration: **Long term* *Skills * - Regulatory Compliance - Should have good experience on Infrastructure validation for GxP applications and its supporting documentation - Should have Good knowledge on GAMP 5 Risk based GxP applications validations and its categories with detailed approach - Should have good knowledge on 21 CFR Part 11 and its assessment for various applications - Should have good knowledge on Annexure 11 and its assessment for various applications - Should have hands on experience in preparation of validation deliverables as per GAMP5 categories - Should have hands on experience in Preparation and execution of test scripts for various qualifications of IQ, OQ and PQ - Should have hands on experience in preparation of Functional Risk Assessment - Should have hands on experience in preparation of System Risk Assessment - Should have hands on experience in preparation of 21 CFR Part 11 assessment and compliance Report - Should have hands on experience in preparation of Annexure11assessment and compliance Report - Should have hands on experience in preparation of Traceability Matrix and Validation Summary Report for various applications - Should have hands on experience in preparation of various supporting SOPs for application, Part 11, Annexure-11 and Infrastructure Qualifications - Should have good knowledge on Periodic Review and schedule, plan, execution and Report for various applications - Should have hands on experience on preparation of MVP and VP - Should have hands on experience in preparation of IQ, OQ and PQ protocols - Should have experience in facing of USFDA audits and internal audits - Should have good communications skills and with good attitude - Should have experience in handling of multiple projects with good coordination *Best Regards..!* *Rajender Reddy* Recruitment Lead E-mail: rajen...@icsglobalsoftinc.com -- You received this message because you are subscribed to the Google Groups "CorptoCorp" group. To unsubscribe from this group and stop receiving emails from it, send an email to corptocorp+unsubscr...@googlegroups.com. To post to this group, send email to corptocorp@googlegroups.com. Visit this group at https://groups.google.com/group/corptocorp. For more options, visit https://groups.google.com/d/optout.
