IT Quality Role - Compliance - Pharma

8.00 to 10.00 Years Mumbai City 16 Jun, 2023

Job Location	Mumbai City
Education	Not Mentioned
Salary	Not Disclosed
Industry	Recruitment Services
Functional Area	IT Operations / EDP / MIS
EmploymentType	Full-time

Job Description

DEPARTMENT: Quality eComplianceLOCATION: Kurla, MumbaiREPORTING STRUCTURE: Reporting to Senior Manager - QeCQUALIFICATION: - Graduate in Science/Pharmacy/Engineering- Post Graduation - Science /MBA (Desirable)EXPERIENCE: - Candidate with 8-15 years of experience in Pharma/Life science domain working on CSV, Part 11/Annex 11, Data Integrity- Work experience at pharmaceutical sites in the capacity of either QA, QC or CSV (preferable). SKILLS AND COMPETENCIES - 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. (Plus)- Experience of validation on automation/digitization projects (Plus)- Good Verbal and Written communication skills (Must)- Aware of industry best practices and knowledge about Pharma 4.0 (Plus)- Functional knowledge of Regulatory guidelines, Quality Control and Manufacturing processes. (Must)- Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) (Plus),

Keyskills :
regulatory guidelinesdata integrityquality control

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IT Quality Role - Compliance - Pharma

Job Description

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