Global Quality Specialist (Assurance)

Location:Craigavon

Hours:37.5 hours per week

Salary:Competitive

Business Unit: Pharma Services

Open To: Internal and External Applicants

Ref No.:HRJOB10268(Please note: if you have applied for this position within the past 6 months, we will be unable to accept your application at this time)

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The Role

The Global Quality Assurance Specialist is tasked with ensuring compliance and governance to global quality standards across all global sites. This role involves the development of key performance indicators and process metrics to measure the performance of the Pharmaceutical Quality System (PQS).

The Global Quality Assurance Specialist will monitor and report on trends within the PQS, engaging with the business to address any issues promptly to maintain operational quality performance. Additionally, they support continuous improvement by reviewing and analysing data collected from key areas within the business.

Job-specific responsibilities include collaborating with Pharma Services sites to develop and enforce Global Quality Standards, monitoring quality systems across sites, and supporting the development of quality process metrics. The Global Quality Assurance Specialist will also:

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• identify and implement continuous improvements
  
• serve as a PQS Element Subject Matter Expert
  
• write and review quality documents
  
• provide QA support in Quality Risk Management
  
• participate in the Global Internal Audit program
  
• support key business and quality projects
  

The role also involves supporting sites during CAPA investigations, hosting forums to promote consistency, developing governance documentation, and supporting regulatory compliance and remediation actions.

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Key Requirements

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• Have eligibility to work in the UK OR possess a valid work permit that will allow you to take up full time employment in the UK
  
• Degree (or equivalent) in a Life Science or technical discipline or related fieldORsignificant experience in a similar technical role in lieu of a degree
  
• Significant experience working within an established Quality System within the Pharmaceutical Industry
  
• Significant experience working within the core Quality Compliance function. e.g. change management, Deviation/investigations, CAPA, product complaints.
  
• Significant experience with the generation, execution and review of quality assurance documents in pharmaceutical manufacturing and/or packaging facility e.g. change management, Deviation/investigations, CAPA, product complaints.
  
• Proven working knowledge of Pharmaceutical legislation and rules governing manufacture and distribution of products
  

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Further Information

The working pattern for this role is a flex pattern between the hours of 07:00 – 19:00 with core hours of 10:00 – 16:00.

*This role requires coverage beyond normal working hours on a regular basis and it is a condition of your employment that you are able to fulfil this requirement of the role.*

You will also be eligible for hybrid working following the successful completion of probation.

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Apply Now

Apply online and tailor your CV to outline how you meet the role criteria. Please upload your CV in PDF format where possible.

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Closing Date

We will no longer be accepting applications after 5pm on21 February 2025

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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 CV’s received or submitted directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.