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Details

QC Analyst Lab Services


Reference:SMC035256 Location: Cork
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QC Analyst, IT Analyst

Summary

We’re currently recruiting for an exciting opportunity with an award winning Pharmaceutical organization based in Cork. This is an excellent opening for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Developing and qualifying the electronic data management processes for the QC team
• Administrating and maintaining Laboratory electronic systems
• Administrate and maintain QC Laboratory systems such as eLIMS, LES, Empower 3, SDMS and Softmax Pro
• Providing day to day operational & training support for laboratory systems
• Completion of necessary software systems documentation reviews including periodic reviews, data integrity reviews and SOP updates.
• Creating and managing Empower projects, user accounts, instrument methods, method sets, report methods and processing templates
• Ensure laboratory systems are compliant with the data integrity requirements of all applicable regulatory guidelines
• Author, review and approve change controls, CAPAs, laboratory investigations, deviations, SOPS and work instructions, qualification protocol, reports etc
• Anticipates and plans for future requirements in the area.
• Deals with events/ deviations in an accurate and timely manner.
• Identifies opportunities to improve the services provided e.g. new technologies, improved vendor processes, cost, quality etc.
• Supports QC where appropriate in meetings and other communications with regulatory authorities, industry meetings, etc.
• Deputizes for the supervisor and other ream members as appropriate.

Education & Experience

• BSc Hons (or Higher) in a Science or related discipline.
• A minimum of 2 years’ experience in a similar role within a laboratory environment
• Working knowledge of Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, Compliant GxP Computerized Systems (GAMP5), service management, IT project lifecycle and other regulatory requirements or policies

If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480