Our client is a global leader in the Pharmaceutical Sector & they are based in Cork. They are currently seeking a QC Analyst for their Lab Services team & the successful person will have experience of LIMS. This role requires strong analytical skills, Excellent communication, written and oral & Acute attention to detail.
The QC Analyst – Laboratory Services will be responsible for the following.
• 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
• Interacts and represents the Cork site on Global COEs related to laboratory systems.
• 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.
• Collaborates across multiple lab groups and with other sites
To be part of this high performing team you will have great attention to detail, alongside
• BSc Hons (or Higher) in a Science or related discipline.
• A minimum of 2 years’ experience in a similar role within a laboratory environment
• Excellent social and communication skills
• 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
• Self-driven and keeps up to date with regulatory, technical developments within the industry.
• Focus on patients and customers at all times.
• Adaptable and flexible
• Excellent team player with strong customer focus
• Knowledgeable of FDA/EMEA regulatory requirements
If you would like further Information you can contact the recruiter directly:
Karen Shiel | Tel: +353 (0) 1 5079256