QA Specialist
12 hours ago
PE Global is currently recruiting for a Senior QA Specialist for a leading multi-national Pharma client based in Dun Laoghaire. NPI and Tech Transfer experience essential for this role This is a contract position. Role: Provide overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes, Validation and Engineering ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations. Quality review and approval of Technology Transfer, Qualification/Validation documentation and SOPs to support site activities. DS, URS & QRAES documents Validation Plans, Protocols, IQ, OQ, PQ and associated documents Executed validation documents and reports Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Qualification/ Validation activities whilst ensuring that all activities meet Amgen and regulatory expectations. Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations Provide Quality direction and input at Change Control Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely. Quality review/approval of BOMs, MBRs and recipes. Write, review and approve Standard Operating Procedures in accordance with Amgen Policies. Perform all activities in compliance with Amgen safety standards and SOPs. In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role Requirements: University degree. Science or Engineering related discipline preferred. Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for NPI/ technology transfer / product lifecycle changes. Understanding of principles of Validation and New Product Introduction Experience in change control, non-conformance, corrective and preventative actions, and validation practices. Ability to operate across functional boundaries, both internal and external. Ability to work independently and remotely with minimum direct supervision. Critical thinking skills. Strong organisational, communication, coordination, and meeting facilitation skills. Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration. Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making. Interested candidates should submit an updated CV. Please click the link below to apply, or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: QA Specialist Technology Transfer NPI
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QA Operations Specialist
7 days ago
Dublin, Ireland Cpl Healthcare Full timeCpl in partnership with SK pharmteco are hiring for a permanent QA Operations Specialist to join the team at the North Dublin site in Swords. ABOUT US? SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of SK Inc., a Korea company with revenues...
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QA Specialist New
2 weeks ago
Dublin, Ireland CPL Full timeCpl in partnership with our client Pfizer are seeking QA Specialist to join the team for an 11 month fixed term contract in their state of the art site in Dublin, Grange Castle. Depending on shift working, this is an onsite role. What You Will Achieve You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will...
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Senior QA Specialist
9 hours ago
Dublin, Ireland PE Global Full timeDescription: PE Global is currently recruiting for a Senior QA Specialist on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role. Overview: 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 be required to...
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QA Compliance Specialist
3 days ago
Dublin, Ireland Headcount Solutions Full timeSnr Specialist, QA Compliance Materials Management An opportunity for has arisen to recruit a QA Compliance Snr Specialist within the Materials Management team of a Dublin based Biotech multinational The successful candidate will support the material qualification and release activities for the new commercial drug product manufacturing facility for its...
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QA Compliance Specialist
3 weeks ago
Dublin, Ireland Headcount Solutions Limited Full timeSnr Specialist, QA Compliance Materials ManagementAn opportunity for has arisen to recruit a QA Compliance Snr Specialist within the Materials Management team of a Dublin based Biotech multinationalThe successful candidate will support the material qualification and release activities for the new commercial drug product manufacturing facility for its...
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QA System and Validation Specialist
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Dublin, Ireland Cpl Resources Full timeThe SK biotek Ireland Quality team at the Swords Campus are looking for a QA Systems & Validation Specialist on a 12 month contract reporting to the Quality Manager. Position Description: The QA Systems Validation Specialist will be responsible for: Assessment of changes for GMP compliance in accordance with site change control procedure for facilities,...
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[Apply in 3 Minutes] QA Specialist
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Dublin, Ireland FRS Recruitment Full timeJoin a Market-Leading Dairy Production Company as a QA Specialist! About The Company: Are you ready to bring your skills to a company with over 35 years of expertise? My client is a leading Dublin-based dairy production company, supplying premium Irish and Continental dairy products to the Catering and Retail sectors. Located just 10km south of Dublin...
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QA Specialist
3 weeks ago
Dublin, Ireland PE Global Full timeThe Role: PE Global are recruiting for a Manufacturing Specialist Investigations Lead to be based in Dun Laoghaire 12 Month initial contract - Hybrid Good technical writing for all deviation incidents, the team must write a thorough write up. So, the candidate must be comfortable with writing clear information and ensure it is detailed. Good project...
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Dublin, Ireland CPL Full timeCpl in partnership with SK pharmteco are hiring for a permanent QA Operations Specialist to join the team at the North Dublin site in Swords. ABOUT US? SK pharmteco is a global Contract Development and Manufacturing organisation (CDMO) with state-of-the-art facilities in Korea, US, France and Ireland. We are part of SK Inc., a Korea company with revenues...
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QA Specialist
3 days ago
Dublin, Ireland PE Global Full timeThe Role: PE Global are recruiting for a Manufacturing Specialist Investigations Lead to be based in Dun Laoghaire 12 Month initial contract - Hybrid Good technical writing for all deviation incidents, the team must write a thorough write up. So, the candidate must be comfortable with writing clear information and ensure it is detailed. Good project...
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3 Days Left: QA Specialist
2 weeks ago
Dublin, Ireland FRS Recruitment Full timeAbout The Company: In operation for over 40 years this company have been the go-to supplier for authentic Asian ingredients and products in Ireland. As one of the country’s largest providers of fresh, frozen, dried, and canned goods, they serve restaurants, caterers, and retail customers with everything they need to create amazing Asian dishes. The...
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QA Operations Specialist
3 days ago
Dublin, Ireland Cpl Resources - TEG Full timeCpl in partnership with our client Pfizer are seeking a QA Operations Specialist to join the team for an 11 month fixed term contract at their state of the art site in Dublin, Grange Castle. This is an onsite role. Every day, Pfizers unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based...
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QA Specialist
2 weeks ago
Dublin, Ireland Cpl Healthcare Full timeCpl in partnership with our client Pfizer are seeking a QA Specialist - Partner Change Control Coordinator to join the team for a 6 month fixed term contract, with Hybrid working at their state of the art Grange Castle Plant, Dublin West. Position Summary This is a temporary contract position for a 6-month term. The contract QA specialist/Sr. Specialist...
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QA Specialist
3 days ago
Dublin, Ireland Cpl Resources Full timeCpl in partnership with our client Pfizer are seeking a QA Specialist - Partner Change Control Coordinator to join the team for a 6 month fixed term contract, with Hybrid working at their state of the art Grange Castle Plant, Dublin West. Position Summary This is a temporary contract position for a 6-month term. The contract QA specialist/Sr. Specialist...
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Dublin, Ireland Life Science Consultants (LSC) Full timeLSC have a great contract opportunity for a Senior Specialist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life. If you have 3+ years industrial experience and are ready for your next challenge, this...
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QA Specialist and Responsible Person
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▷ Urgent Search! QA Stability Specialist
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Dublin, Ireland Cpl Healthcare Full timeCpl in partnership with our client Pfizer are seeking a QA Stability Specialist to join the team at their state of the art plant in Dublin, Grange Castle for an 11 month fixed term contingent contract. This is a hybrid working role. Why Patients Need You Everything we do, every day, is in line with an unwavering dedication to the quality and the delivery...
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Dublin, Ireland Cpl Resources Full timeCpl in partnership with our client Pfizer are seeking a QA Specialist - Partner Change Control Coordinator to join the team for a 6 month fixed term contract, with Hybrid working at their state of the art Grange Castle Plant, Dublin West. Position Summary This is a temporary contract position for a 6-month term. The contract QA specialist/Sr. Specialist...
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[1/28/2025 A] QA Specialist
1 week ago
Dublin, Ireland PE Global Full timeThe Role: PE Global are recruiting for a Manufacturing Specialist Investigations Lead to be based in Dun Laoghaire 12 Month initial contract - Hybrid Good technical writing for all deviation incidents, the team must write a thorough write up. So, the candidate must be comfortable with writing clear information and ensure it is detailed. Good project...
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Senior QA Validation Specialist
3 days ago
Dublin, Ireland PE Global Full timeDescription: PE Global is currently recruiting for a Senior QA Validation Specialist on behalf of a leading biotech company based in Dublin South. This is an initial 18-month contract role. Overview: We are seeking an experienced Senior Quality Assurance Professional to provide quality direction and oversight for activities related to the installation of new...
