Bristol Myers Squibb QA Operations Specialist in Mulhuddart, Ireland
Bristol-Myers Squibb is currently building a new state of the art large-scale biologics manufacturing facility in Cruiserath, Dublin 15, approximately $1 billion investment. Once completed, 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 permanent QA Specialist specializing in QA Operations. Reporting to the QA Operations Manager, the QA Specialist will provide QA oversight and support construction, 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.
Responsibilities will include (but not limited to):
QA support of manufacturing operations through start-up and onto routine commercial operations
Implementation of batch record review process and on the-floor support of manufacturing activities
QA Operations review of events and investigations
Authoring, review and approval of QA-related procedures
Review and approval of functional area documentation
Support the Disposition process for Drug Substance and ensure material availability for Manufacturing through release of raw materials and consumables
Participation in GMP reviews for new facility construction and new equipment support systems
QA support for implementation of Manufacturing Execution System (MES) and development of batch records
QA support for implementation of the BMS Enterprise Resource Planning System (SAP) including data verification and integration testing for the Quality function
Change control assessment and CAPA evaluation/CAPA close-out
Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements
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, with at minimum 3 years’ QA or related experience in a Pharmaceutical environment. A clear understanding of cGMP requirements for manufacturing and/or systems and compliance.
The QA Specialist will be required to work on his/her own initiative in addition to working as part of a team, and must be open to shift work. The candidate must be able to work across a team matrix in order to meet accelerated timelines. Excellent communication & presentation skills are essential. The successful candidate must demonstrate excellent time management & organisational skills along with a proven ability to multi-task.
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.