Company : Bristol Myers Squibb Location : Boudry Neuchâtel From : Neuvoo CH
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This position is part of Quality Assurance department in Boudry and is responsible for executing the review and approval of all relevant qualification/validation deliverables.
The position will support projects deployment at Boudry site.
Duties and Responsibilities You will be responsible and accountable for the tasks given below :
Will provide regulatory compliance support across the end-to-end product lifecycle for validation lifecycle activities associated with equipment qualification, cleaning, and process validation to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and BMS requirements:
Participate as Quality Compliance Validation representative to the site and global project implementationReview and approval of qualification and validation documentation (e.G risk assessment, protocol, report, validation plan).Review / approve deviation, problem, incident, changes that occurred during qualification/validation of equipment/systems.Operate effectively and with minimal supervision, within a team or independently, performing projects and related duties, as assigned.
Support the QA team to perform evaluation of deviations, CAPA, and change control in his area of responsibility.
Assists with writing and reviewing documents (procedure, work practice) prepared by SMEAs required, provides QA support to SMEs to ensure the compliance to procedure /industry standards.
Support as QA validation the periodic review and requalification of equipment/processes to ensure that systems are maintained in a validated state Skills/Knowledge RequiredUniversity graduate (science degree preferred),Experience in the Biotech/Pharmaceutical Industry or similar, regulated industry requiredAt least 3-5 years of experience in Quality Assurance area related to qualification/validation in a pharmaceutical company or other regulated industry.Excellent understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.Good understanding of solid oral dosage form manufacturing/packaging and QC processes.Knowledge of most common office software (e.G Microsoft Office word, excel, PowerPoint).Experience with Change Control, Deviation Management and Risk management Quality Systems.In-depth understanding of equipment qualification (included automated systems), cleaning and/or process validation.
Computerize Validation experience (CSV) is a plus.Previous experience in risk-based approach to qualification/validation is a plus.Good understanding of the drug development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processesExcellent analytical, interpersonal and communication skills, including written and verbal communicationWorks independently, yet effectively in a team environment.Able to deal with ambiguity and identify/mitigate risks.Strong sense of ethics, diplomacy and discretionStrong critical thinking to analyze complex situations and discern critical issuesAbility to manage various projects, create and work within internal timeliness, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional teamExcellent team player attitude 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.
BristolMyersSquibb 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. BristolMyersSquibb BoudryNeuchâtel
