Senior GMP Auditor

Job Overview

Norbrook are seeking to recruit a Senior GMP auditor to join the core auditing team within the Corporate Quality Assurance team.

Main Activities/Tasks

• Conducting On-Site, Virtual and paper based external audits/inspections of current and potential API suppliers, Packaging suppliers, sub-contractors and service providers across the globe, to assess the compliance of the organisations with their GMP obligations. This will include the planning and report writing associated with the audits.
• Manage the annual audit program of suppliers, sub-contractors and service providers as required and aligned with the other auditors within Norbrook Laboratories Limited.
• Review of all incoming audit reports from the Norbrook auditors and third party contractors to ensure consistency of approach and observation categorisation
• Assessing the adequacy of CAPA responses from inspected organisations and assuring timely closure of same through regular review
• Assist with the maintenance of the risk register established for all Norbrook’s suppliers/manufacturers and third party contractors.
• Conducting internal audits/inspections of departments within Norbrook Laboratories Limited, both scheduled and ad hoc, to assess the compliance of departments with GMP requirements.
• When required, review the evidence of CAPA closures throughout the Norbrook facilities and support structure

Essential criteria:

• Bachelor’s degree (or equivalent)
• Significant experience in the pharmaceutical industry.
• A minimum of three years’ experience conducting GxP audits
• Extensive experience performing both internal and external audits
• Strong knowledge of cGMP, quality system standards, and regulatory requirements such as 21 CFR, ICH, ISO, etc.
• Ability to evaluate suppliers against different quality system standards
• Ability to communicate effectively and constructively across departmental and external functions.
• Strong written and interpersonal communication skills.
• Ability to travel approximately 35–40% of the working year
• Ability to handle multiple responsibilities and job tasks, as needed

Desirable criteria:

• Bachelor’s degree in a physical science (Chemistry, Biology, etc.)
• Experience performing international audits
• Experience in a vendor management role
• Qualified Lead Auditor status, e.g., IRCA

Duration: Permanent

Location: Newry

• Training and development will be provided for the right candidate and continuous support will be available from the core audit team members and Subject Matter Experts from within the company
• 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.

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
On-site free parking
Subsidised canteen facilities
WeCare programme – supporting the local community
Employee perks 
Employee recognition scheme
Career development opportunities

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.