QMS & Ops Compliance Manager

Job Overview

Reporting to the QA Site Lead, based within the Quality Department, the successful candidate will be responsible for handling of quality investigations arising from identified deficiencies as reported from external and internal sources such as customer quality complaints, Out of Specification results, deviations etc. and for co-ordinating the implementation of corrective and preventative actions to address identified deficiencies. Working within the site team to implement Quality Management Systems and Continuous improvement projects within the manufacturing environment.

Main Activities/Tasks

The main duties of this role will include but will not be limited to the following:

• Investigating, Documenting, and Reporting of Customer Complaints, Deviations, OOS, CAPAs and other quality non-conformances.
• Participating, as a key contributor, in GMP audits by regulatory authorities and by contract customers and implementation of associated corrective and preventative actions.
• Working alongside Operations in the implementation, maintenance and improvement of the QMS within the manufacturing environment.
• Trending and analysing of quality data and contributing to the continued development of the company and promoting all aspects of cGMP.
• Assisting in the approval of SOP’s, PCRs, PQRs and other quality documentation.

Essential Criteria:

• Minimum Education: Third level qualification.
• Minimum 3 years’ experience within a GMP environment.
• Excellent knowledge of GMP and Quality Management Systems.
• Excellent oral and written communication skills.

Desirable Criteria:

• Experience in a Quality Assurance role.
• Knowledge of current regulatory requirements, in both the EU, and the US.
• Experience with solid dose manufacture.
• Experience with aseptic manufacturing.

Duration: 1 X Full time, permanent
1 X FTC 12 month contract

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.

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
• Tech Purchase Scheme
• Salary sacrifice scheme
• On-site free parking
• Subsidised canteen facilities
• WeCare programme – supporting the local community
• Employee perks scheme
• Employee recognition scheme
• Career development opportunities

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.