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:
1. Review and approval of all manufacturing batch documentation including electronic batch records, real time reports, master data using the site systems.
2. Review and approval of SOP's, cleaning verification/validation data and other documents as necessary for the IPT department.
3. 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.
4. Support the development and implementation of improved quality reporting measures.
5. Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
6. Verification of the effective implementation of key GMP programs
7. Effectiveness of Preventative Actions
8. Provide training in all aspects of Quality Management Systems and GMP.
9. Ensure all work is carried out in line with SOP's, training or other quality systems such as change controls where applicable.
10. 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 :
11. Third Level Degree qualified in a Science/Technical or related discipline.
12. Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
13. Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site.
14. 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 rachel.kent@lifescience.ie for further information.