What you need to know
You will work a QA Specialist for our client, a leading Animal health company in Co. Offaly. This company is a world leader in the discovery and delivery of quality veterinary vaccines, medicines and diagnostic products, complemented by biodevices, genetic tests and precision livestock farming.
The QA Specialist will play an active role in support of the general site quality system, and in addition, all 3rd party, regulatory, technology transfer, operational and audit initiatives.
The QA Specialist will support the ongoing maintenance and continuous improvement of existing QA process and SOPs across all disciplines.
Reporting to: The Quality Operations Manager
This is a Permanent role
Your new job
Key duties & responsibilities:
- Lead the vendor management process to include vendor assessments, auditing and qualification.
- Lead supplier change notification process for the site.
- Partake and contribute to internal and external audits and conduct on site audits as required. Analyse audit outcomes and implement appropriate corrective procedures.
- Prepare Quality agreements with required Vendors.
- Participate in ongoing site data integrity projects.
- Oversee and support site Material requirement specifications.
- Support site risk management procedures.
- Support the ongoing site training system and deliver training modules where required.
- Review of batch records for Cell Culture operations and Purification operations to ensure compliance with the requirements of cGMP and the validated process.
- Provide QA support to Quality Control including review of QC raw data.
- Support change management, deviations and CAPA systems as required.
- Assist in supporting the qualification and periodic review of equipment.
- Manage specific projects that may arise, in a timely and efficient manner.
- Support ongoing running and maintenance of Electronic Quality Management System.
- Participate in set up of new electronic systems where required.
What are we looking for?
- Third level Degree in a life science discipline.
- At least 3 years Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP.
- Strong vendor management experience.
- Experience of interaction with cross-departmental teams.
- Excellent interpersonal and communication skills, meticulous eye for detail.
- Computer literate.
- Strong time management awareness and the ability to drive projects forward.
Apply for this job now or get in touch with Aoife on Aoife.firstname.lastname@example.org
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