QA BMR Reviewer
| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 3959 |
| Job Views | 133 |
- Description
Team Horizon is seeking a QA BMR Reviewer for an initial 12-month contract at our clients manufacturing site in Dublin. The role will report into the QP & QA Ops Manager and is responsible for production support, postproduction review (BMR) or a quality system (i.e. Triage, Document Change Control, document Annual Review, etc.)
Why you should apply:
- Opportunity to join a fast paced manufacturing site and work with an established team of quality professionals who strive for excellence and high-quality performance results.
What you will be doing:
- 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 Annex 16.
- BMR and Logbook issuance through SAP, POMs and One Vault systems.
- Manage and perform BMR/Logbook control, reconciliation, archiving, retrieval and returns through Iron Mountain (IM) system.
- Carry out and monitor established QA/GMP programs.
- Responsible for the management of the retain system for samples and documents.
- Provides assistance in departmental and regulatory audits.
- Has the ability to train a colleague in a particular GMP procedure or related activity.
- Participate in department initiatives and projects.
- Represent the QA BMR review team in cross functional meetings and provide the current documents review status.
What you need to apply:
- 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 organizational, communication and interpersonal skills.
- Ability to set and maintain the highest standards.
- Ensures compliance to procedures, policies and guidelines and adherence with cGMP regulations, company policies and guidelines at all times.
- Always Demonstrates an ethos of Right First Time.
- Must quickly become familiar with products and processes
