Computer System Validation

Urgent Requirement for Rabale MALE Candidate
Knowledge Required:- Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV,GAMP 5 (Must) Good knowledge of Data Integrity requirements for Pharma (Must) Experience of working at Pharma Site QC,QA,IT,CSV etc Must Experience Candidate with 3 - 5 years of experience in Pharma/Life science domain working knowledge in authoring on Computer System Validation Deliverables, Part 11/Annex 11, Data Integrity Work experience in Pharmaceutical Sector will be desirable Experience in Authoring all CSV deliverables e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc Experience on validation of any of the enterprise level applications. e.g. Documentum, LIMS, LMS, , etc. Author, review and approval of SOPs, Guidelines/Policies as applicable. To have functional knowledge of Regulatory guidelines, Quality and Manufacturing processes. A team player with good communication skills (verbal & written)