Compliance & Operational Support Analyst

Job Overview

The successful candidate will ensure the QC Micro department operates in a safe, efficient and compliant manner and deliver to the needs of our customers.

Main Tasks/Activities:

• Compilation and approval of MOA’s, SOPs, Test Protocols, Reports, Raw Material Specifications, Finished Product Specifications and Packaging Specifications in accordance with GMP
• Review and approval of logbooks ensuring compliance to GMP
• Trending and reporting of analytical data and generation of key KPI’s
• Preparing for and participation in regulatory and customer audits.
• Assist investigations into OOS & OOT results and determination of root cause
• Approval of analytical data and preparation and approval of Certificates of Analysis
• Assist in the training of staff
• Raising, investigating and closing change controls, deviations and other key QMS parameters
• Management of computerised systems within the department, from introduction, qualification and completion of ongoing review
• Completion of periodic reviews and oversight of standalone computer system requirements
• Champion adherence to Health and Safety requirements and drive a culture of improvement within the laboratory
• Identify and deliver projects that lead to improved compliance (Quality and EHS) and efficiency gains
• Maintain a CAPEX forecast plan
• Any other duties as deemed necessary by management
• Working through the QA department, you will have the responsibility to approve and control the issuing of Working Copy Documents for the recording of data within the GMP environment

Essential Criteria:

Applicants must therefore demonstrate the following essential criteria on their application form in order to be considered:

• Possess a degree in a science related discipline OR have a minimum of 3 years relevant experience in a laboratory setting
• Have a minimum of 2 years relevant experience in an analytical laboratory setting
• Use of Trackwise for the creation and closure of change controls and the creation, investigation and closure of deviations
• Experience of computer system validation (csv) requirements throughout the whole system lifecycle
• Practical use of root cause analysis tools
• Practical knowledge of laboratory instrumentation and microbiology analytical methods
• Experience in training other analysts

Duration: Full Time, Permanent

Location: Newry

Additional Information:

• This role will be based in a site that produces and handles penicillin, and as such, this role would not be suitable for those that have a penicillin allergy.
• Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
• We regret that applications received after the closing date and time will not be accepted.

Contact: recruitment@norbrook.co.uk

Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community.