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Purpose The Technical Services Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance. The Technical Specialist will provide processing expertise to support the technology transfer, process validation and routine commercial manufacturing for Upstream and/or Downstream manufacturing. The Technical ...

Company: Recruitment by Aphex Group (5 days ago)

This is an 11-month initial contract. Purpose This position within the QA department will provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the Company priorities of: Compliance, Supply, Strategy and Profit Plan. The team working style is one of collaboration, coaching and ...

Company: Recruitment by Aphex Group (1 day ago)

This is a 12-month contract with a view to extension. This is an onsite role. Purpose Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, sample, and data management. Contributes to the team by ensuring the quality of the tasks/services provided by self Contributes ...

Company: Recruitment by Aphex Group (6 days ago)

Note - this role is open to hybrid working, no set days, details to be confirmed further in January Purpose The Manufacturing Specialist (Investigation Lead) will be primarily responsible for leading investigations for fill/finish/inspection and packaging deviations. Specialists will also be involved in applying process, quality, compliance, and ...

Company: Recruitment by Aphex Group (6 days ago)

Purpose The role requires the individual to perform a series of tasks to guarantee the quality of our products and processes, and adherence to the Quality Management system. The responsible person will contribute to the organisation of quality control and process validation activities as well as interacting with various stakeholders in the business ...

Company: Recruitment by Aphex Group (6 days ago)

This is a 12-month contract with a strong view to extension. Purpose The Plant Quality Assurance (PQA) Snr Associate will report to the QA Manager and will be a core member of the site Quality Assurance team. The PQA Snr Associate will serve as Quality point of contact for manufacturing operations. The site is focused on continuous improvement of ...

Company: Recruitment by Aphex Group (6 days ago)

Purpose The role requires the individual to perform a series of tasks to guarantee the quality of our products and processes, and adherence to the Quality Management system. The responsible person will contribute to the organisation of quality control and process validation activities as well as interacting with various stakeholders in the business ...

Company: Recruitment by Aphex Group (6 days ago)

This is an 11-month initial contract. Purpose The Quality Systems Compliance Specialist is responsible for maintaining and continuous improvement of our Quality Management System throughout their knowledge and areas of expertise. Ensure that objectives are effectively achieved, consistent with our requirements to ensure compliance, safety and ...

Company: Recruitment by Aphex Group (5 days ago)

This is a 12-month contract with a strong view to extension. It is a hybrid position but candidates need to be commutable to the site. Quality Assurance Specialist-QA Technical Support Purpose The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Manager and will ...

Company: Recruitment by Aphex Group (2 days ago)

This is a 24-month contract with a view to extension. This is a hybrid position but the candidate needs to be commutable to the site. Purpose The Plant and Technical Quality Assurance (PTQA) Specialist is a senior position within the QA function which will typically report to a QA Manager and will be required to be a Subject Matter Expert in their ...

Company: Recruitment by Aphex Group (2 days ago)

This is a 12-month contract with a view to extension. This is an onsite role. Responsibilities Testing of in-process, stability, and finished product samples. eg HPLC, CE, SDS-PAGE, IEF analytical testing, characterization, and sample and data management. Review and authorization of Lab Data Support Analytical Technical Transfer activity testing ...

Company: Recruitment by Aphex Group (6 days ago)

Purpose The role will be responsible for providing data analytics support to enable data-driven decision making, building foundational capability to provide visibility into business processes and implementation of advanced analytics solutions to drive value. Additionally, the role may involve carrying out additional work functions that are not ...

Company: Recruitment by Aphex Group (6 days ago)

This is an 11-month contract and is a hybrid position. Purpose The purpose of this role is to work within and support the Global Development Quality Assurance team at the BioNX Research & Development Division facility in Dunboyne. This role will primarily provide support for SAP Quality Master Data build, Master Data approvals hypercare, ...

Company: Recruitment by Aphex Group (1 week ago)

Purpose This role will serve as technical support for new product introduction (NPI) and commercial manufacturing and will participate and/or lead cross functional or single function teams including liaising with vendors or above site groups. Typically have prior related work experience; ideally in manufacturing, preferably GMP Setting but we will ...

Company: Recruitment by Aphex Group (2 weeks ago)

Purpose The Project Manager Process Development will report to the Sr. Manager Process Development in the Portfolio Management and Delivery (PMD) group and will be responsible for managing new product introduction and lifecycle management projects for drug product (DP) and finished drug products (FDP). The successful candidate will have at least ...

Company: Recruitment by Aphex Group (2 weeks ago)

This is an 11-month initial contract and is a hybrid position. Purpose The QA Operations role will lead Quality Assurance activities at the BioNX, Research & Development Division facility. The role is a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of ...

Company: Recruitment by Aphex Group (2 weeks ago)

This is a 12-month is a hybrid position, Purpose The Validation & Tech Transfer (TT) Specialist will be responsible for developing and maintaining validation (process and cleaning validation, continued process verification) and TT guidance and supporting toolkit to support implementation in a consistent manner across products and sites. This will ...

Company: Recruitment by Aphex Group (2 weeks ago)

Purpose The position reports to the Laboratory Systems Lead. The position offers the opportunity to work with a team of professionals in a modern analytical laboratory using the most up to date technology and quality assurance procedures. The laboratory operates under Lean principles and employees the use of a wide variety of analytical techniques ...

Company: Recruitment by Aphex Group (3 weeks ago)

Purpose Reporting to the API Reliability & Systems Lead, the SIS Co-ordinator operates in a team based, continuous improvement environment within the Engineering CoE (Centre of Excellence) and works closely with colleagues from Projects, Automation & IT, Operations, and Maintenance EHS with support from external SME resources to implement ...

Company: Recruitment by Aphex Group (3 weeks ago)

Purpose The Technical Administrator will work within the Maintenance Systems team to keep the Engineering Documentation and CMMS (Computerised Maintenance Management System) updated. Responsibilities Manage documentation related to Maintenance Systems for the site handed over from Projects (e.g. P&IDs, OEM manuals, etc) Register new equipment and ...

Company: Recruitment by Aphex Group (3 weeks ago)