Exciting Opportunity for an experienced Quality Assurance Manager to join our client, Ortec, in their state-of-the-art European HQ in Newcastle West, Limerick!
Join a Thriving Start-up: Be part of a dynamic start-up environment with limitless potential and opportunities for growth and impact. As the Quality Assurance Manager, you will play a crucial role in developing and maintaining the Quality Management System (QMS) at their cutting-edge facility along with leading and providing supervision to their highly skilled Quality team.
Overview of responsibilities: Full job description available on request.
- Delegate and oversee QA work assignments to ensure compliance with statutory and regulatory requirements, including ISO 13485, FDA 21 CFR 210/211 cGMP, and IPEC Excipient standards
- Provide quality management oversight for existing products covering supply chain, production and post-production processes to meet customer and Ortec NCW requirements
- Organize and direct continuous improvement activities to improve process efficiency, product compliance and control
- Serve as the site quality representative for management and customer relations
- Provide quality assurance oversight throughout the product engineering and risk management process for the development of new products, including review and approval of equipment qualification protocols and reports, process validation protocols and reports and related documents
- Review and Approve design and process evaluations including development of material and product specifications, test methods and risk analysis (e.g. DFMEA, PFMEA, Control Plans)
- Review and Approve documents and forms according to good documentation practices (GDP), e.g. SOP’s, batch records, lab reports, raw and intermediate material control records, etc. for accuracy and completeness
- Review and Approve problem analysis/complaint investigations where necessary, e.g. QE and CAPAs (OOS, Deviations, Complaints and NC investigation and closeout)
- Review and Approve change controls and Document change requests
- Participate in customer product reviews and Review and Approve Quality Agreements
- Abide by company and ISO 14001/45001 safety standards set for work area
- Oversee quality audits (internal, customer, agency, and third party)
- Serve as Management Representative for ISO 13485.
- Report to top management on the effectiveness of the quality management system and any need for improvement.
Qualifications and Experience:
- Advanced Degree: Masters or Doctorate Degree in Sciences, Regulatory Sciences, or Engineering; alternatively, a Bachelor's Degree with a minimum of 5 years of experience as a QA Manager or Supervisor.
- Validation Expertise: Extensive knowledge of process, test, and equipment validation, enabling effective quality assurance oversight.
- Industry Experience: Minimum 5-10 years' experience in regulated chemical, pharmaceutical, or medical device manufacturing environment, showcasing expertise in conducting quality audits and implementing CAPA systems.
- Professional Certifications: ASQ Certification is preferred, with SS Green Belt or Black Belt qualifications desirable.
For a confidential discussion and more information on the role, please contact Barry O'Brien
barry.obrien@collinsmcnicholas.ie
021-4911060
