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The Senior Specialist, QC Incoming will be responsible to ensure the technical capabilities for the QC Incoming testing laboratory. The QC Specialist, Incoming testing will support activities related to the Pharmacopeial compendial review, evaluates impact of compendial changes on applicable QC procedures and handles related change controls. In this role, you will also play a critical role in supporting method development and validations related to raw materials as well as supporting investigations and resolution of issues.
Skills/Knowledge Required
- CFC as Laboratory Technician or BS degree in Science, Chemistry, or equivalent.
- Advanced understanding of pharmaceutical regulatory requirements (cGMPs, JP, JPE, USP and Ph. Eur) and their impact to incoming material operations.
- Advanced understanding of technical capability of instrumentation, software and techniques used in Incoming testing.
- Experience of analytical testing according to Ph. Eur., JP and USP requirements.
- Experience in analytical method transfers and analytical method validation/verification.
- Good scientific knowledge of chromatography techniques (HPLC, UPLC, GC) and wet chemistry techniques.
- General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
- Good knowledge of Data Integrity principles, familiar with audit trail review requirements.
- Effective verbal communication skills, ability to interact with different levels of the organization: supervisor, peers, lab analysts, and other departments.
- Effective technical writing skills, experience writing GMP documents (procedures, protocols, plans and reports) as well as deviations and investigations.
- Professional command of French and English, verbal and written. • Proven time management skills and a strong attention to detail.
- Proven analytical and problem-solving skills.
- Ability to work independently and compliantly.
Duties and Responsibilities
Performs all activities in compliance to cGMP requirements as well as to EHS rules and safe work practices per applicable procedures.
Maintains the GMP status of QC incoming operations:
- Establish incoming testing specification for the release of raw materials, Document rational for the establishment of testing
- Evaluates impact of compendial changes on applicable QC procedures and handles change controls as required
- Performs or supports feasibility experimental work as needed
- Lead and support method transfer, method verification and method validation activities, both internally and externally with contract testing laboratories.
- Writes analytical methods, verification protocols and reports, specifications, operating procedures. Ensure training of QC personal on incoming testing methods and procedures.
- Owns or support change controls related to incoming testing methods changes
- Leads or supports investigations in case of incoming testing-related deviations. Defines CAPA.
- Evaluate and process contract testing laboratories change notifications for impact to incoming materials
- Represents QC in cross-functional project teams supporting New Product Introductions, Material Qualification and Material Risk Assessment processes for excipients.
- Performs other tasks as assigned and project work
Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.
Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.
