QA Compliance Specialist
3 days ago
Our client based in Sligo are looking to hire a QA Compliance Specialist on an initial 12 month contract. The Role: As the QA Compliance Specialist you will be responsible for documenting and establishing a quality system which ensures full compliance with all regulatory standards. You will be responsible for reporting on the effectiveness of the quality system to senior management. Responsibilities: Coordinating the quality system, ensuring full compliance by all personnel with its requirements. Coordination of Product Quality Reviews activities. Management of all Technical Agreements from initiation, review, approval and storage. Coordination and Management of all Track and Trend activities to support Manufacturing and QC. Driving a QRM approach to all activities on site. Coordination and facilitation of all Site RCS and FMEA activities. Auditing the quality system per the documented internal audit schedule. Assisting in the documentation, investigation of and coordinating customer complaints/exceptions by ensuring implementation of effective corrective / preventive action where necessary. Ensuring that products manufactured at Company XXX meet requirements of end users, of regulatory authorities and of the company. Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings. Coordinating change management, change control and Change planning activities. Monitoring quality performance and advising management personnel on major quality issues. Liaison with AbbVie Global Quality Assurance, FDA, HPRA and other regulatory bodies. Regulatory review. Initiation and Completion of Quality related investigations and verification of the effectiveness of CAPAs as required. Establishing Corrective / Preventive Action system and procedures. Management of the Supplier program including the ASL, Performance metrics and Audit Schedules Creation and approval of commodity specifications as required Performance of Vendor audits as required Support all aspects of inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of proof books. Adheres to and supports all EHS & E standards, procedures and policies Requirements Third level degree in a science, quality or engineering discipline. A minimum of three years experience in a quality/operations role in a highly regulated manufacturing GMP environment (Pharmaceutical/Biologics/Medical Device) A strong knowledge of regulatory requirements is required. For more information and a confidential discussion on the role please contact Michelle Mc Inerney. Skills: Quality Systems Engineer
-
QA Compliance Specialist
3 days ago
Sligo, Co. Sligo, Ireland Gertek Project Management Full timeGerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all...
-
QA Compliance Specialist
1 week ago
Sligo, Ireland Collins McNicholas Recruitment Full timeOur client based in Sligo are looking to hire a QA Compliance Specialist on an initial 12 month contract. The Role: As the QA Compliance Specialist, you will be responsible for documenting and establishing a quality system which ensures full compliance with all regulatory standards. You will be responsible for reporting on the effectiveness of the quality...
-
[Apply in 3 Minutes] QA Compliance Specialist
3 weeks ago
Sligo, Ireland Gertek Project Management Full timeGerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all...
-
QA Manufacturing Compliance Specialist
2 weeks ago
Sligo, Ireland Orion Group Full timeOrion Group Life Sciences are currently recruiting QA Manufacturing Compliance Specialist on behalf of our Multinational Biopharmaceutical client based in Sligo on an initial 12-month contract with huge potential to extend. Shift Details: Rotating day and evening shift. Days: 07:00 - 15:00 Evenings @ 16.7%: 15:00 - 23:00 Must haves: 1. Providing quality...
-
QA Validation Engineer
3 days ago
Sligo, Co. Sligo, Ireland Gertek Project Management Full timeGerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all...
-
QA Operations Specialist
3 days ago
Wicklow Town, Co. Wicklow, Ireland Servier Industries Ltd Full timeReporting to the QA Operations Manager and working as part of the QA Operations team, the successful candidate will be expected to carry out the role and responsibilities of the job function in an autonomous and responsible timely manner to meet all related targets and deadlines while maintaining good relations with, and flexibility within your team and...
-
QA Specialist
3 days ago
Carlow Town, Co. Carlow, Ireland Life Science Consultants (LSC) Full timeLSC have a great contract opportunity for a QA Specialist to join a global Biopharmaceutical company in Carlow. This is a state-of-the-art vaccines and biologics manufacturing facility currently producing many products in various therapeutic areas including: oncology, autoimmunity, pneumonia, and infectious disease. If you have 3 years of experience working...
-
QA Specialist
3 days ago
Carlow Town, Co. Carlow, Ireland Life Science Recruitment Ltd Full timeQA Validation Specialist (New Product Introduction) 11 month contract On site Carlow AMC22404 I am on the lookout for a QA Specialist for Validation and NPI for a rapidly expanding biotechnology manufacturer in Carlow. You will be an essential member of the Technical transfer and Validation team responsible for managing development and manufacturer of...
-
QA Validation Specialist
3 days ago
Carlow Town, Co. Carlow, Ireland PE Global Full timeThe role: PE Global is currently recruiting for a QA Validation Specialist on behalf of a leading pharmaceutical company based in Carlow. This is an initial 11-month contract role. Description: Carlow is offering an amazing opportunity for a Quality Assurance Specialist to join our quality team. In this role, you will play a vital role in supporting the...
-
QA Associate Specialist
3 days ago
Carlow Town, Co. Carlow, Ireland Life Science Recruitment Ltd Full timeQA Associate Specialist - Shift RK22685 Contract 11 months On site - Carlow Were currently recruiting for an exciting opportunity with a multinational Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational at an exciting growth period. Duties Responsible for ensuring manufacturing...
-
Urgent: QA Validation Engineer
2 weeks ago
Sligo, Ireland Gertek Project Management Full timeGerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects with our technically strong personnel ensuring all...
-
Louth, Co. Louth, Ireland WuXi Biologics Ireland Limited Full timeCompany description: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The...
-
QA Specialist
3 days ago
Carlow Town, Co. Carlow, Ireland Recruitment by Aphex Group Full timeThis is an 11-month initial contract. Purpose In this role, you will play a vital role in supporting the introduction of new products and Quality oversite of executed validation completed at our Carlow facility. As the QA Specialist for Validation and New Product Introduction (NPI), you will be an essential member of our esteemed Technical...
-
Apply in 3 Minutes! Electrical Engineer
2 weeks ago
Sligo, Ireland PE Global (UK) Full timeQA Manufacturing Compliance Specialist (Biologics) Job Dept: Quality Assurance Reports to: Quality Operations Manager Responsibilities - Ensure that all products leaving meet the standards required for marketed and investigational drug products. - Ensure that products and aseptic process simulations manufactured meet the requirements of the end users,...
-
QA Specialist
3 days ago
Carlow Town, Co. Carlow, Ireland Headcount Solutions Full timeQuality Assurance Specialist Validation and NPI An amazing opportunity has arisen for a Quality Assurance Specialistto join the quality team within a leading Biopharmaceutical Multinational. As a member of the Tech Transfer/Validation Team you will play a vital role in supporting the introduction of new products and Quality oversite of executed validation...
-
Associate Specialist QA
14 hours ago
Carlow Town, Co. Carlow, Ireland Recruitment by Aphex Group Full timeThis is an 11-month contract and is a 2-shift cycle. This is an onsite role. Purpose Responsible for ensuring that the process for the manufacture of drug products at our Carlow site complies with cGMP and the associated regulatory requirements. Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations...
-
Senior TPM R&D Specialist
37 minutes ago
Sligo, Ireland Abbott Laboratories Full timeAbout Abbott Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life....
-
Quality Inspector
3 days ago
Sligo, Co. Sligo, Ireland FRS Recruitment Full timeJob Title: Quality Inspector - Documentation Control We are recruiting a full-time Quality Inspector - Documentation Control (Maternity Leave Cover). Responsibilities: Inspect incoming materials and finished products for quality. Perform environmental monitoring and document results. Conduct problem-solving, audits, and update QA documentation. Support...
-
EHS Specialist
3 weeks ago
Sligo, Ireland Team Horizon Full timeEHS Specialist IITeam Horizon is seeking a EHS Specialist II (initial 12-month contract) for our client who is a leader in the global biopharmaceutical industry, for their manufacturing site in Sligo. Our client is developing the capability to produce all its medicines, helping to ensure continuity of supply of our medicines as they expand...
-
Quality Inspector- Fixed Contract
14 hours ago
Sligo, Co. Sligo, Ireland Brightwater Full timeQuality Inspector- Fixed Contract About the Company My client is one of Ireland's leading companies in Medical Device Engineering and they currently have an opportunity for a talented Quality Inspector to join their team. About the Position This client is currently recruiting for full-time Quality Inspector Documentation Control (Specific Purpose contract...