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The BMS site of Boudry is a Manufacturing Site for Oral Solid Dosage Drugs and a Center of Excellence for projects and New Product Introductions (NPIs) relying on flexible manufacturing and testing operations. Currently, a Global ERP Integration project is on-going (switch from Oracle ERP to SAP ERP) at the Boudry site. The QA SAP Senior Specialist - Quality Projects & Vendors will join the Quality Assurance team of BMS, Switzerland.

The position is supporting all quality relevant activities (like change control, User Acceptance Test scripts writing and execution for SAP Quality Module) and is responsible for executing the review and approval of all relevant documents related to the implementation of the New SAP ERP at Boudry site.

You will be responsible and accountable for the tasks given below for BMS Boudry. The list of tasks is non exhaustive, according to business needs other tasks might be assigned to you.

Will provide Quality & Compliance support to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and BMS requirements for the following task:

Participate as Quality counterpart for the review and approval of change controls, deviations and documents (Standard Operating procedures, Work practices) related to the global project implementation,

Execute Risk assessment as required.

Write, execute, review and approve User Acceptance Test Script for the SAP Quality module.

Participate to the update/creation of documentation related to the implementation of the quality module in SAP.

Participate to the GMP readiness of the new ERP.

Support the Quality validation team for the review / approval of qualification documents.

The position holder will operate effectively and with minimal supervision, within a team or independently, performing projects related duties, as assigned.

Promote compliance with data integrity and cGMP/GxP regulations.

As required, provides QA support to SMEs to ensure the compliance to procedure / industry standards.

Adherence to BMS core behaviours

Specific Knowledge, Skills, Abilities:

Good understanding of solid oral dosage form manufacturing, packaging and QC processes is a plus.

Experience with Change Control, Deviation Management and Risk management Quality Systems.

Experience in Quality end-to-end processes,

Good understanding of Electronic Batch record (MES) or System Applications and Products in Data Processing (SAP) for quality related activities.

Excellent analytical, interpersonal and communication skills, including written and verbal communication in French and in English.

Works independently, yet effectively in a team environment.

Able to deal with ambiguity and identify/mitigate risks.

Strong sense of ethics, diplomacy and discretion

Strong critical thinking to analyze complex situations and discern critical issues

Knowledge of most common office software (e.g Microsoft Office word, excel, PowerPoint).

Ability to collaborate various projects, create and work within internal timeliness, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional team,

Excellent team player attitude

Education/Experience/ Licenses/Certifications:

University graduate (science degree preferred),

At least 5 years of experience in Quality Assurance area related to qualification/validation in a pharmaceutical company or other regulated industry.

Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.

Wir setzen uns auf der ganzen Welt leidenschaftlich daf\\xc3\\xbcr ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrit\\xc3\\xa4t bef\\xc3\\xa4higen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das h\\xc3\\xb6chste Potenzial jedes unserer Kollegen hervor.

Bristol Myers Squibb wei\\xc3\\x9f um die Bedeutung von Balance und Flexibilit\\xc3\\xa4t 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.\\n \\n \\n \\n \\n \\n

\\n\\n Bristol-Myers Squibb\\n \\n\\n

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