QA BMR Reviewer – North Dublin

Desired Skills: batch review,qa,batch manufacturing records

PE Global are currently recruiting for a QA BMR Reviewer for our client site in North Dublin on a 12-month initial contract:

QA BMR REVIEWER/TECHNICIAN

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.

Requirements:

• 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.

Ownership/Accountability:

• Ensuring 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

Demonstrated Behaviors:

• Consistently lives values, even when it might be unpopular or personally inconvenient to do so. Sets a personal example that reinforces culture, reputation, and standards.
• Demonstrates open communication and info action-sharing, consistently keeping all stakeholders informed of own and team deliverables.
• Demonstrates ability to collaborate with colleagues across other functions and influence positively and skillfully to find common ground to achieve organizational goals.
• Understands and supports the need for change and involves self in change initiatives and continuous process improvements.
• Demonstrates the desire and ability to grow own capabilities by seeking out and engaging in challenging learning opportunities that enhance contribution to site and advance professional and career development.
• Demonstrates a personal commitment to site safety by actively fostering a safety culture and upholding all safety standards in the performance of job duties.
• Exhibits a high personal drive for excellence and holds self-accountable for consistently high-quality performance results.

 Interested candidates should submit an updated CV, marked for the attention of Audrey

audrey.mccarthy@peglobal.net  or  00353 21 4297900