Senior Specialist, Sterile Drug Product, QA Manufacturing Operations
20 hours ago
Senior Specialist, Sterile Drug Product, QA Manufacturing Operations role at Bristol Myers Squibb UK & Ireland. The role supports the startup of a commercial sterile drug product manufacturing facility and, post startup, the execution and maintenance of QA activities related to commercial sterile drug product manufacture and release on shift in Cruiserath. The position involves working with project teams to address questions during project design, construction, and qualification, and providing QA oversight across all phases.
Key Responsibilities During Start Up- Provide QA oversight for Aseptic Sterile Drug Product processes (Formulation, Filling, Lyophilization, Capping, AVI).
- Collaborate with project design, CQV, and Automation/CSV teams to facilitate implementation and validation of Drug Product Operations.
- Prepare/review/approve documentation (SOPs, MBRs, Logbooks) and complete training on time.
- Support CQV / Tech Transfer / Operational Readiness activities, including New Product Introduction, SOP development, training material development, MES/MBR design, and CQV support as required.
- Develop and execute training programs for multiproduct manufacturing.
- Support Operational Excellence initiatives (e.g., 5S, Std Work, LSW, Kaizen, problem solving).
- QA support of manufacturing operations (commercial operations and new product introductions).
- Batch record review and on-the-floor support of manufacturing activities.
- Quality oversight for the inspection program.
- QA operations review of events and investigations.
- Authoring, review, and approval of QA-related procedures; review/approval of functional area documentation.
- Support disposition process for commercial and clinical drug products.
- Participation in GMP reviews for new facility construction and new equipment support systems.
- QA support for MES implementation and development of batch records.
- Change control assessment and CAPA evaluation/close-out.
- Interface with relevant departments to ensure compliance with GMP and regulatory requirements.
- Support external and internal audits.
- Drive and support a culture of continuous improvement and safe working practices.
- Designee for Manager, Sterile Drug Product, QA Manufacturing Operations when required.
- Support Operational Excellence initiatives (5S / Std Work / LSW / Kaizen / Problem Solving).
- BSc in Science or related discipline with 2-3+ years of QA Operations or related experience in biologics or pharmaceutical environments.
- Clear understanding of cGMP requirements for manufacturing and/or systems and compliance.
- Detailed knowledge of Sterile Drug Product is advantageous.
- Ability to work independently and as part of a team; open to shift work; ability to operate within a matrix to meet deadlines.
- Excellent communication and presentation skills; strong time management and organizational skills with ability to multi-task.
- Demonstrated BMS Biopharma Behaviors and commitment to safety and quality.
If you come across a role that intrigues you but doesn't perfectly line up with your resume, you are encouraged to apply anyway. You could be one step away from work that will transform your life and career.
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