Sr. Associate
4 months ago
A Computer Systems Quality Sr. Associate is required to join a global biotech company based in Limerick. This role will be fully on site in a brand new start of the art manufacturing facility and will play a critical role in maintaining the quality and regulatory compliance of our biopharmaceutical products. You will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives. Key Responsibilities: Develop and maintain quality assurance procedures, policies, and systems. Conduct routine self-inspections and monitoring assessments (time-on-the-floor) to ensure compliance with cGMP (current Good Manufacturing Practices) and other relevant regulations. Collaborate with automation, IT and production teams to ensure quality throughout the manufacturing process. Investigate and address deviations, non-conformities, and CAPA (Corrective and Preventive Actions) to maintain quality. Participate in IT and process automation organizations to provide consistency across all computer systems areas. Ensure compliance with periodic review, change control, deviation, back up and archive, security, and other support processes for systems. Develop common local procedures for Computer systems and help the site consistently interpret and implement global policies across all computer systems areas. The Person BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline. 3+ years of experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment. Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements. Excellent problem-solving and analytical skills. Detail-oriented with a strong commitment to maintaining high-quality standards. Effective communication and teamwork skills. Experience with quality management systems (e.g., TrackWise) and automation systems (e.g., DCS, DeltaV) is a plus. For further details please contact;Paula OReillyon or send CV in confidence to Skills: QA Experience CSV Experience GMP Experience
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Sr. Associate
5 months ago
Limerick, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. About Us: Eli Lilly Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility is at the...
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Sr. Associate
6 months ago
Limerick, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. About Us: Eli Lilly Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility is at the...
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Senior Associate
6 months ago
Limerick, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you...
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Sr. Consultant, Compliance- 12 month FTC
3 weeks ago
Limerick, Ireland Northern Trust Full timeAbout Northern Trust: Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring...
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Sr. Consultant, Compliance- 12 month FTC
6 months ago
Limerick, Ireland Northern Trust Corporation Full timeAbout Northern Trust: Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889. Northern Trust is proud to provide innovative financial services and guidance to the world’s most successful individuals, families, and institutions by remaining true to our...
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Limerick, Ireland Lilly Full timeWe’re looking for people who are determined to make life better for people around the world. Organization Overview: This position will initially support site readiness from a Competitive Continuous Improvement (CCI) perspective and will transition to support CCI activities once the site is operational. Responsibilities: The Competitive...
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Limerick, Ireland Regeneron Ireland DAC Full timeThe QA Specialist/Sr QA Specialist for External Drug Product Manufacture provides QA oversight to ensure that drug product manufacturing activities are compliant with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents. A typical day might include, but is not limited to, the following: Reviewing and...
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Sr Statistical Programmer
4 weeks ago
Limerick, Ireland Pharmiweb Full timeDescription Senior Statistical Programmer Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to...
