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Details
Associate QA Specialist (Shift)
Reference: | AMC20711 | Location: |
Carlow |
Qualification: | Degree | Experience: | 2-3 Years |
Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
QA Specialist
Associate QA Specialist (Shift)
AMC20711
11 Months
Carlow
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties:
- Review and approval of all manufacturing batch documentation including electronic batch records, real time reports, master data using the site systems.
- Review and approval of SOP's, cleaning verification/validation data and other documents as necessary for the IPT department.
- Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with same.
- Support the development and implementation of improved quality reporting measures.
- Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
- Verification of the effective implementation of key GMP programs
- Effectiveness of Preventative Actions
- Provide training in all aspects of Quality Management Systems and GMP.
- Ensure all work is carried out in line with SOP’s, training or other quality systems such as change controls where applicable.
- Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis. Be an advocate of continuous improvement in the Quality Management Systems.
Education and Experience :
- Third Level Degree qualified in a Science/Technical or related discipline.
- Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
- Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site.
- GMP Audit experience in the pharmaceutical industry
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or [email protected] for further information.
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