My client a leading Pharmaceutical company now require a Quality Assurance Associate – Biologics to join their rapidly expanding team.
The Quality Assurance Associate – Biologics is responsible for the coordination of quality activities within the Quality Assurance group in a start-up Manufacturing facility.
This is a permanent role based in Dublin and it comes with a good salary with good benefits.
Responsibilities of Quality Assurance Associate - Biologics
- Coordinate and execution of batch record review
- Coordinate and execution of cleaning record review
- Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
- Support activities relating to the Quality Management System (QMS), which include, but not limited to; CAPAs, change control, material and service supplier management.
- Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews for products manufactured on site.
- Participate in the on-site GMP Inspection schedule
- Participate in the internal audit schedule.
- Participate and support the Environmental monitoring program me
- Develop SOP & other GMP Controlled Documents.
- Review of master records.
- Support activities relating to customer complaints, product returns and product recall
- Support the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
- To actively support the development/implementation of continuous improvement activities.
- Participate in other projects as directed by the Quality Assurance Executive
Requirements of Quality Assurance Associate - Biologics
- Bachelor's degree in chemistry, biology or a related scientific discipline.
- Minimum 2 years’ experience in quality in the pharmaceutical industry.
- Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas.
- Understanding of quality and cGMP's.
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below