A QA Associate is required for a biopharmaceutical company in West Cork. The incumbent will provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site.
- This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment.
- The team working style is one of collaboration, coaching and facilitation to ensure the success of the site.
- The Associate Specialist is accountable for the Quality Systems within the site.
- Provides to the site knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/ Investigations/LIR coaching; GCM coaching, environmental monitoring program, sterility assurance/low bio-burden manufacturing, customer complaint investigations etc.
- Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
- Provides compliance contribution to project teams and leads small projects.
- May coach and guide colleagues within the site.
- Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
- Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
- Supports Corporate Quality to ensure actions related to Quality Systems and/or Operational Quality at the site are executed.
- Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
- Ensure supply of high quality product through the implementation and oversight of the Quality Management System for the site.
- Ensure the highest Quality, Compliance and Safety standards.
- The Associate Specialist will participate and comply with the company’s Quality Management System (QMS) requirements, including ownership.
- Responsible for driving a culture of Continuous Improvement by deploying the company’s Six Sigma tools within across operational areas.
- The Quality Associate Specialist/ Specialist will have proven capability in development of Quality Systems as an active member, across cross functional teams, to deliver process improvement.
- Model the company’s Leadership behaviours and understand the company’s principles to drive a culture of continuous improvement building a High Performance Organisation.
Qualifications & Experience:
- Degree or 3rd level qualification (Science, Quality).
- 1 – 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function.
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (i.e. Quality, science etc.).
- Operational experience of at least 4 QMSs.
To apply for this job email your details to firstname.lastname@example.org.