What you need to know
Matrix Recruitment Group are currently recruiting for a number of QA Specialists for our client in the Pharmaceutical industry based in Offaly.
These are permanent positions.
Your new job
- Review & approval of batch records for Cell Culture operations and Purification operations to ensure compliance with the requirements of cGMP and batch review and batch disposition process.
- Partake in QA documentation control centre, resolve documentation issues that may arise and help produce relevant metrics to monitor efficiency.
- Support change management, deviations and CAPA systems as required.
- Provide QA support to Quality Control including review of QC raw data.
- Review and approval of non-conformance reports including deviations, laboratory investigations & environmental excursions.
- Partake in Internal and External audit program.
- Support ongoing running and maintenance of Electronic Quality Management System.
- Support the ongoing site training system and deliver training modules where required.
- Partake in the vendor management process to include vendor assessments, auditing and qualification and supplier change notification. Support site Material requirement specifications.
- Prepare Quality agreements with required Vendors.
- Participate in ongoing site data integrity projects.
- Support site risk management procedures.
- Overview product and cell bank stability programmes, submission of samples, filing of results and providing updates.
- Assist in supporting the qualification and periodic review of equipment.
- Manage specific projects that may arise, in a timely and efficient manner.
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.
- Good knowledge of regulatory and cGMP guidelines and directives, including product certification, validation, quality control and manufacture including QbD and Risk Management.
- 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 via the link below
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