Overview
Quality Assurance Specialist Jobs in Dublin, County Dublin, Ireland at PE Global
Title: Quality Assurance Specialist
Company: PE Global
Location: Dublin, County Dublin, Ireland
The role:
PE Global are currently recruiting for a QA BMR Reviewer on behalf of a leading pharmaceutical company in North Dublin. This is an initial 12-month contract role.
Description:
The QA BMR reviewer has a primary area of focus such as production support, postproduction review (BMR) or a quality system (i.e. Triage, Document Change Control, document Annual Review, etc.). The position incumbent is expected to adhere to all cGMP compliance, regulatory mandate and quality requirements, and comply with all related global and internal SOPs, policies and procedures in the performance of job duties. The BMR reviewer applies skills and knowledge to recognize and resolve issues that impact efficiency, throughput, quality and/or the fulfilment of the assigned performance target.
Responsibilities:
- 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.
Education and Experience:
- 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.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to [email protected]
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
