QA GLP Inspector

Job Overview
The QA GLP Inspector is responsible for conducting inspections and generating audit reports within the R&D GLP Division to ensure compliance with Good Laboratory Practice Guidelines (SI 3106) and OECD GLP standards published as OECD Principles on Good Laboratory Practice (Revised 1997, ENV/MC/CHEM (98)17) and the requirements of Directive 2004/9/EC and 2004/10/EC and associated national legislation. Assist in the upkeep of a current and effective Quality Management System in accordance with Regulatory Authority requirements, company standards and best practices.

Essential Criteria:

• Educated to degree level in a relevant life science related discipline or a minimum of two years’ relevant experience working within a GLP or GMP environment. (Full training will be provided).
• Previous laboratory experience, including reviewing data using Empower (CDS).
• Experience in maintenance and trending of deviation and laboratory Investigation systems.
• Experience in managing Change Control.
• Demonstrate the Ability to read and interpret laboratory procedures, methods and data, GLP and regulatory guidance.
• Strong attention to detail.
• Excellent organisation and communication skills (written and verbal) across a range of interdepartmental levels.
• Demonstrate the ability to work independently on assigned responsibilities as well as part of a team to a high standard to meet deadlines.
• A full driving licence is required.

Desirable Criteria:

• Experience working in a QA function in a GLP or GMP environment.
• Experience in the approval, introduction and control of study and facility related documentation.
• Experience developing and maintenance of Excel spreadsheets for tracking purposes.
• Understanding of bio-analysis
• Demonstrable experience in a Clinical setting (in-house and/or CROs etc.,) working on clinical and non-clinical studies operating to GLP
• Understanding of Good Laboratory Practice principles and standards and quality management systems
• Knowledge of FDA/EMA practices and guidelines
• Knowledge of Pharmacovigilance (PV) guidelines and previous experience of conducting PV audits.
• Experience in the trending and interpretation of analytical data
• Experience of preparing responses to regulatory queries

Duration: Full time, permanent
Location: Newry

Additional Information:

• Applicants should have a right to work in the UK at the time of their application (proof required). 

Benefits:

• Free Life Assurance
• Company Pension Scheme
• Healthcare cash plan
• 32 days annual leave
• Wedding Leave
• Company Sick Pay
• Employee well-being initiatives
• Employee Assistance Programme
• FREE on-site parking
• Canteen Facilities
• Employee Perks scheme
• Annual Employee raffle
• Employee Recognition scheme
• Career development