Eurofins Scientific is a group of international life sciences companies which provide a unique range of analytical testing services to clients across multiple industries. The Group believes it is the global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies. In addition, Eurofins is one of the leading global emerging players in esoteric and molecular clinical diagnostic testing.
Post : CSV Specialist
Skills - CSV, Compliance, Validation, IQ OQ PQ, GAMP5, Empower, GLP, GMP, 21 CFR part 11
Qualification : Graduate / Postgraduate - (BE/BTech/M Pharm/ M Sc.)
Experience : 2-4 years in any CRO/Pharma organization
Job Description
• Be a subject matter expert on computer system validation and data integrity requirements compliance.
• Write & perform evaluations, reviews, risk assessments and testing of computerized systems considering the principles of GAMP5, 21 CFR Parti 1, EU Annex 11 and OECD along with internal procedures.
• Software validation and revalidation activities like preparation and execution of validation documentation including risk assessments, IQ, OQ, PQ Protocols and reports, traceability matrices, and validation reports.
• Preparation of Standard Operating Procedures (SOP’s).
• Represent compliance team for all sponsor/regulatory audits and related queries.
• Reviewing vendor validation documentation & coordinating the validation and troubleshooting activities.
• Software administration and maintenance support (Empower, Watson LIMS, Analyst, etc.)
• Perform BCP/DRP activities for computerized systems.
• Perform periodic review of the computerized systems.
• Maintain up to date software inventory.
Location: Bangalore and Hyderabad
Send resume For
BLR - hr@advinus.com
For HYD - hr.hyd@advinus.com
Please mention “Position Applied For" in the subject line. Ex- CSV Specialist Please note that you need to have served your current organization for at least 1 year to be eligible for consideration at Eurofins Advinus.
Last Date : 30th January, 2024
See All B.Pharm Alerts M.Pharm Alerts Ph.D Alerts Bangalore Alerts
See All Other Jobs in our Database
.png)
