Technical Quality Specialist Location: Craigavon Hours: 37.5 hours per week Salary: Competitive Business Unit: Pharma Services Open To: Internal & External Applicants Ref No.: HRJOB10192 ? The Role In this role within the Technical Quality team at Almac Pharma Services, the successful applicant will play a crucial part in ensuring compliance with GMP principles and the company's quality standards. The responsibilities include overseeing a variety of validation activities to ensure that essential facilities, systems, processes, and procedures meet the EU and FDA requirements in a timely manner. This involves active participation in the validation life cycle stages, such as developing project design documentation, risk assessment of validation requirements, generating validation plans, preparing protocols and reports, and analysing process validation data. The role involves collaborating with various stakeholders, providing advice on validation procedures, monitoring equipment and processes, managing workloads to meet client needs, and serving as the lead representative during the initiation of new projects. The position also entails monitoring and re-evaluating equipment, systems, and processes periodically, ensuring appropriate system access for users, supporting satellite Pharma Services sites, and updating management on validation project statuses. The successful applicant will work closely with project teams, plan validation tasks, participate in testing to meet operational needs, review and approve documentation for system and process releases, and assist in regulatory compliance remediation actions. By providing guidance to internal and external stakeholders, managing workloads effectively, and ensuring timely completion of validation tasks, the successful applicant will contribute significantly to maintaining high-quality standards and regulatory compliance within Almac Pharma Services. ? Key Requirements 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 A HND (or equivalent) level qualification OR Relevant experience within scientific, engineering or IT related discipline Experience or working knowledge of an established quality system (e.g. GMP, ISO) ? 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. You will also be eligible for hybrid working following the successful completion of probation. ? 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. ? Closing Date We will no longer be accepting applications after 5pm on 02 December 2024 ? 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. Skills: quality systems GMP Experience ISO Standards Benefits: Flexible Schedules Work/Life Balance Employee Referral Bonus Free onsite parking Group Healthcare Scheme