Quality Assurance Specialist

Quality Assurance Specialist (Fixed Term: 9 - 12 months)

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Location: Craigavon

Hours: 37.5 hours per week

Salary: Competitive

Business Unit: Pharma Services

Open To: Internal and External Applicants

Ref No.: HRJOB9859

*Please note if you have applied for this role within the past 6 months and have been unsuccessful, your application cannot be reconsidered*

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The Role

This role involves assessing and improving the Quality System of Almac Pharma Services and contributing to GMP (Good Manufacturing Practice) compliance and the quality of pharmaceutical products. The main responsibilities include monitoring and reviewing various operations such as manufacturing, quality control, analytical support, product development, and engineering to assess ongoing GMP compliance and product quality. The role also involves providing quality assurance support and advice to operational departments, implementing quality systems like deviation/CAPA (Corrective and Preventive Action) management and change controls, and actively improving quality systems to ensure GMP compliance and product quality. The successful candidate will also be involved in reviewing production and laboratory data, participating in the Supplier Management Process, conducting internal and external audits, and assisting in the compilation and review of various reports and agreements.

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In addition to the above, the post holder will be the internal and external contact for queries related to product compliance and quality. They will also participate in audits of external suppliers and assist in hosting customer and regulatory audits. The role requires the identification, writing, approval, and implementation of critical GMP documents, as well as conducting internal audits and assisting in the compilation and review of Product Quality Reviews, Technical Agreements, and Risk Assessments. Additional duties related to ensuring GMP compliance and product quality may also be assigned.

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The ideal candidate for this role should have a strong understanding of GMP compliance and quality systems. Attention to detail, analytical skills, and the ability to review data and reports for accuracy are crucial. Excellent communication and organizational skills are essential for interacting with internal and external stakeholders and ensuring timely delivery of projects while maintaining product quality. The role also requires the ability to conduct audits and participate in the Supplier Management Process. The successful candidate should be proactive in continuously improving quality systems and demonstrating a commitment to GMP compliance and the quality of pharmaceutical products.

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Key Requirements

• Degree (or equivalent) in a Life Science or closely related field OR Significant experience working within the Pharmaceutical Industry along with demonstrable knowledge may be considered as sufficient to meet educational requirements for this role.
• Significant experience working within an established Quality System (e.g. GMP, ISO)
• Comprehensive, working knowledge of the regulatory requirements for pharmaceutical products are essential, including familiarity with the principles of Good Manufacturing Practice, Pharmaceutical Quality Systems, Quality Risk Management and Pharmaceutical Product Lifecycles

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Further Information

These roles are based on a flex work pattern: Monday – Friday between the hours of 07:00 – 19:00 with core hours of 10:00 – 16:00. These roles 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 on 09 October 2024

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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.