QA BMR Reviewer

QA BMR Reviewer - Ireland, Dublin - 12 Month Contract

Located near Dublin, our global pharmaceutical client is seeking a QA BMR Reviewer to join their state of the art manufacturing facility. The company focuses on investing in research and development to drive scientific innovation and deliver life changing medicines. With thousands of employees worldwide and continued growth across their network, this is an excellent opportunity to join a leading organisation shaping the future of healthcare.

What you'll do:

• Review of Intermediate and Finished Product Batch Manufacturing Records and any other batch related documents for completion and accuracy.
• Review of Critical Process Parameters (CPPs) of BMRs to ensure the filed processes are met.
• Raise and support the completion of Triages, DCRs, CAPAs, Non conformances and Change Controls.
• Review, collate and submit the necessary documentation to support QP release of finished product in accordance with Annex16.
• BMR and Logbook issuance through SAP, POMs and One Vault systems.

What you'll need:

• A third level qualification in a scientific discipline, preferably a B.Sc./M.Sc.
• Pharmaceutical experience with good working knowledge of cGMP.
• Strong knowledge of FDA/EMEA regulatory requirements.
• Excellent organisational, communication and interpersonal skills.
• Ability to set and maintain the highest standards.