Did you know that your Internet Explorer is out of date?
To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
Name:
Surname:
Email:
Phone:
Cv:
Salary Expectations:
Education:
Experience:
Current Location:
Notice Period:
Write here your cover note:
If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box
If you are having difficulty you can always email your cv to applications@lifescience.ie
Sr. Associate - Quality for Computer Systems Validation
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.
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 O’Reillyon 087 7094141 or send CV in confidence to paula.oreilly@lifescience.ie
#J-18808-Ljbffr