Location: Craigavon, Northern Ireland, UK

Hours: 37.5 Hours Per Week. Flexible working pattern.

Business Unit: Almac Sciences

Open To: Internal & External applicants

Ref No.: HRJOB9689/1

The Team

The Quality Compliance team at Craigavon are part of a global quality team, working to ensure patient safety, regulatory compliance, and product quality in an efficient and effective manner.

The team consists of Quality Compliance and Quality Validation teams. Team members are involved in all aspects of GMP operations across the site, performing quality inspections to verify GMP activities and act as a supportive/advisory role, both in the manufacturing and analytical laboratories.

As a contract organization, Quality is at the heart of our relationship with customers, therefore involvement in customer communications, visits and site audits may also form part of the role.

The Role

Quality Compliance Officers participate in Quality Compliance activities and GMP improvement initiatives throughout Almac Sciences.

Analytical Services provides support to analytical projects and operations, including review of quality related documents. The post holder will also be responsible for performing reviews of Quality issues (unplanned deviations and OOS) and assist in the management the Quality Management System, supporting operations to ensure it is effective, efficient and compliant.

As part of a busy team within a rapidly growing organisation, operating within a challenging industry you will benefit from the numerous personal and professional developmental opportunities available throughout the Almac group.

Essential Candidate Criteria

Degree level (or equivalent) qualification in a Life Science related discipline
Minimum 2 years’ experience working in a quality or laboratory environment operating to GMP principles or recognised quality system (e.g. ISO)
Strong understanding of analytical documentation, including but not limited to analytical method validation reports and certificates of analysis.

Desirable Candidate Criteria

Experience working in a Quality Assurance role, supporting the analysis of APIs or Drug products
Experience of preparation and or reviewing analytical documents such as analytical method validations reports
Experience performing investigation into quality issues such as Unplanned Deviations and OOS’s
Experience of review of analytical data for example Stability data
Experience of performing internal audits to identify GMP compliance gaps

Reward

For the successful candidate, we offer an attractive benefits package which will include a competitive salary, annual bonus, employer pension contributions, 34 days paid annual leave, healthcare benefits and much more. Please see further details on the Benefits Tab.

Closing Date: Sunday 15th September 2024 at 17:00

Please note: This is a readvertisement. If you have applied for this role within the past 6 months, we cannot consider your application. Sorry for any inconvenience caused.

RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role by our Talent Acquisition team. Speculative candidate CVs received or submitted directly to Hiring Managers will be considered unsolicited, and no fee will be payable. Thank you for your cooperation.

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Quality Compliance Officer – Analytical Services