Bristol Myers Squibb QA Senior Systems Specialist in Cruiserath, Ireland
Bristol-Myers Squibb has built a new state-of-the-art Multi-Product Cell Culture biologics manufacturing facility in Cruiserath, Dublin 15, approximately a $1 billion investment. The new facility will significantly increase Bristol-Myers Squibb’s biologics manufacturing capacity and play a central role in its global manufacturing network.
BMS Cruiserath Biologics is seeking to recruit a QA Systems Senior Specialist to join the Quality Systems team. The QA Systems Senior Specialist will provide QA oversight and support qualification and validation, technical transfers, regulatory approvals and commercial operations. The role will also support the biologics Drug Substance manufacturing operations through start-up and onto routine commercial operations. In addition, the QA Systems Senior Specialist will support CBQC function responsible for release testing and batch certification for finished drug product.Key responsibilities will include (but not limited to):
Administration of Product Quality Complaints (PQC) including processing, and maintenance of site PQC program for all licensed products.
Administration of the site APQR program.
Administration of Change Control system including assessment.
Support the QA Documentation systems on site.
Support and maintain the Quality Risk Management program.
Co-ordination and support of Regulatory and Corporate Inspections.
Interface with the relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
Authoring, review and approval of QA-related procedures.
Development of site training curricula, training material and SOPs for the site training program.
Support Quality Council and Quality Site Metrics generation.
Support OPEX programs and champion continuous quality improvement initiatives.
Qualifications and Experience required:
The successful candidate will hold a BSc in Science or related discipline
A minimum 5 years QA experience in a biopharma environment
A clear understanding of cGMP requirements for manufacturing and/or systems and compliance.
Sound experience of regulatory processes and requirements for FDA, EU and global markets.
Excellent communication & presentation skills are essential. The successful candidate must demonstrate excellent time management & organizational skills along with a proven ability to multi-task.
Employees are expected to display the BMS Biopharma Behaviours, which enable them to be successful and perform at their highest level.
The BMS Behaviours are: Passion, Innovation, Accountability and Speed.
Why should you apply:
You will help patients in their fight against serious diseases and you will increase the survival of more people with cancer
You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 23.5 days annual leave plus 3 Company days, life assurance, on-site gym and gain-sharing bonus.
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We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.