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Senior Associate Computer Systems Quality Specialist
2 weeks ago
We are seeking an experienced Senior Associate Quality for Computer Systems to join our team in Limerick. As a key member of our quality assurance department, you will play a critical role in maintaining the quality and regulatory compliance of biopharmaceutical products within our next-generation manufacturing facility.
This is an exciting opportunity for a highly motivated individual to work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
The ideal candidate will have a strong background in quality assurance, with experience working in a biotechnology, pharmaceutical, or medical device manufacturing environment. They will be well-versed in cGMP, FDA, Data Integrity, Quality Risk Management and other biopharmaceutical regulatory requirements, and possess excellent problem-solving and analytical skills.
The successful candidate will be responsible for developing and maintaining quality assurance procedures, policies, and systems. They will conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations, and collaborate with automation, IT and production teams to ensure quality throughout the manufacturing process.
Key Responsibilities:
- Develop and maintain quality assurance procedures, policies, and systems.
- Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations.
- Collaborate with automation, IT and production teams to ensure quality throughout the manufacturing process.
Requirements:
Skills and Qualifications:
Avoiding Gaps in Quality Assurance Processes
To succeed in this role, you will need a minimum of 3 years' experience in quality assurance within a biotechnology, pharmaceutical, or medical device manufacturing environment. You will also need a BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
Key Skills:
- BSc, Hons BSc, MSc, or PhD in Science, Engineering, Quality, or related discipline.
- Minimum of 3 years' 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.
Benefits:
Competitive Salary and Benefits Package
This role offers a competitive salary and benefits package, including a comprehensive pension scheme, life assurance, and income protection. We also offer flexible working hours and a generous holiday entitlement.
Continuous Professional Development
We are committed to supporting the ongoing professional development of our staff. This includes access to training courses, workshops, and conferences, as well as mentorship opportunities and career progression.
Quality Focused Culture
We operate in a fast-paced, dynamic environment where attention to detail and a focus on quality are essential. Our team is passionate about delivering high-quality products and services, and we strive to maintain the highest standards in all aspects of our work.
