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Position Summary
BMS Cruiserath Biologics is seeking to recruit a Senior Specialist, QA Manufacturing Operations for Sterile Drug Product.
Reporting to the Manager, QA Manufacturing Operations for Sterile Drug Product, the Senior Specialist(s) will support the start-up of a commercial drug product manufacturing facility for its biologic’s commercial portfolio and clinical pipeline. This shall be achieved by working in conjunction with the project team to provide resolution on questions as they arise during project design, construction, and qualification. Providing quality assurance oversight for all phases of the project.
In addition, this role will support readying the facility for manufacturing operations on a 24/5 basis, supporting the Tech Transfer program for new products introduced into the facility.
Post start-up the successful candidate will support the execution and maintenance of the QA activities related to the commercial sterile drug product manufacture and release activities on shift in Cruiserath. This is a 24/5 shift role.
The start-up nature of this project will require adaptability & innovation due to the multiple project phases and multiple products onsite. The role will be both challenging & rewarding and will thus ensure that the successful candidate can seize a wide range of development opportunities within BMS. The Sterile Drug Product project scope includes construction and commissioning of new SDP product suite with parts prep, formulation, aseptic filling and capping of liquid & freeze-dried vials, aseptic filling of syringes, and Visual Inspection capabilities. The project also includes new and expanded clean utilities.
Key Responsibilities During Start Up
Provide QA oversight for Aseptic Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping, and AVI.
Work with the project design, CQV, & the Automation/CSV teams to facilitate the implementation of the project design and validation of the project for Drug Product Operations.
Prepare/Review/Approve documentation (SOPs, MBRs, Logbooks) required to enable manufacturing start-up and complete training on time.
Support CQV / Tech Transfer / Operational Readiness activities including but not limited to:
New Product Introduction
SOP Development and Implementation
Training Material development
MES / MBR Design
CQV support as required
Develop and execute training programs in support of multiproduct manufacturing.
Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.
Key Responsibilities During Commercial Operations
QA support of manufacturing operations (commercial operations and new product introductions)
Batch record review and on the-floor support of manufacturing activities
Provision of quality oversight for the inspection program
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 commercial and clinical drug product.
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
Change control assessment and CAPA evaluation/CAPA close-out.
Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory…