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 Activities/Tasks

• Compilation of Standard Operation Procedure, Method of Analysis, Equipment Qualification Test Protocols, Reports, Raw Material Specifications, and Finished Product 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.
• Reading and recording of test results. Approval of analytical data.
• Assist in the training of staff in new and existing techniques.
• Ensure that adequate stocks of all laboratory consumables are available.
• 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.
• Perform monthly backup and data archive for the computerised system.
• 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.

Essential Criteria:

• Possess a degree in a science related discipline OR have a minimum of 2 years relevant experience in a laboratory.
• Possess good communication skills, written and oral as demonstrated on their application form and at interview.
• Demonstrate good organisational skills, be flexible, motivated, and willing to work shift patterns when necessary.
• Demonstrate the ability to work as part of a busy team as well as working on own initiative.

Desirable Criteria:

• Use of Quality Management Software like Trackwise for the creation and closure of deviation and change controls.
• Experience of computer system validation (csv) requirements throughout the whole system lifecycle.
• Practical knowledge of laboratory instrumentation and microbiology analytical methods.
• Experience in training other analysts

Duration: Permanent

Location: Newry

Additional Information:

• 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.
• We are unable to sponsor or take over sponsorship of a Visa at this time.
• This role is based on a site that produces penicillin and as such, would not be suitable for those with a penicillin allergy.

Contact: recruitment@norbrook.co.uk

Norbook 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.