Quality Control Supervisor for EM/Utilities
Shire
Neuchâtel, Switzerland
vor 3 Tg.
source : Experteer

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do.

We live our values of Takeda-ism Integrity, Fairness, Honesty, and Perseverance and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives including your own.

An exciting and challenging opportunity has become available at Takeda’s Neuchatel Manufacturing plant (approx. 650 employees) for an experienced Quality Control Supervisor for EM / Utilities About the roleThis is an exciting career opportunity within the Quality Control department for a dynamic, autonomous, agile, and striving for continuous improvement professional.

The successful person for this job will work closely with the different manufacturing unit teams in a world-class Biotech manufacturing environmentThis role, will supervise, in collaboration with the QC Manager, the laboratory in charge of Environmental Monitoring, and waters and gases testing, ensuring reliable and timely availability of test results under cGMP.

The Quality Control Supervisor will also act as a backup of the QC Microbiology Manager in his functions of management and documents approval.

This position is responsible for handling various QC projects, such as implementation of new equipment or methods. Main accountabilitiesSupervise the Environmental Monitoring and Utilities team activities to assure timely availability and accuracy of results.

Define daily priorities for the laboratoryCoach and develop team membersEnsure training of lab techniciansEnsure timely availability of required testing capabilities and supportive documentationEnsure that all samples are analyzed in accordance with SOPs and regulatory requirements to applicable GMPs and standards.

Own personal accountability for all EHS aspects, ensuring his / her team is operating in a safe workplace. Understand and apply Takeda EHS guidelines and commitments policy, taking care of his / her own safety as well as of the team, report at risk situations and improvement opportunities to supervisory personnelSupport implementation and validation of new equipment and methodsOwn deviations and handle investigations related to EM or UtilitiesDrive continuous improvement in the EM lab (5S) and Lean CultureEnsure audit readiness in the laboratory, subjects preparation and presentation during auditParticipate to different project teams depending on expertise and project focusCollaborate appropriately with the Global Quality Microbiology teamEducation and Experience University degree in microbiology or life scienceMinimum 8 years of experience in Environmental Monitoring or QC microbiology labAt least 6 years of experience in people managementGood knowledge of FDA, EMA, ICH regulations and Quality system standardsFluent in French and English (B2 written and spoken)Preferred QualificationsTechnical expertise of different microbiological methods (bioburden, bacterial endotoxin test, TOC, EM, etc ).

Ability to balance workload and timelines taking into account the customer needsStrong knowledge of aseptic filling processes as well as sterility assuranceGood communication with customers and suppliers (external and internal)Knowledgeable in inspection against Regulatory / Quality standardsKnowledge / Experience with Quality tools such as Trackwise®Excellent computer skillsAbility to synthesize complex information and to speak confidently in front of an audienceExperience as a project leader is a plusWorking EnvironmentFull time job, daily working hours Monday-FridayNotice to Employment / Recruitment Agents : Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department.

Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal.

Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal.

Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration. Full time

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