Quality Control Manager Job at Takeda Pharmaceuticals in Zürich, ZH
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us our Quality Control Manager in our office in Zurich, Switzerland.
Here, you will be a vital contributor to our inspiring, bold mission.
As our successful Quality Control Manager your duties will focus around non-laboratory support of the Quality Control functions. Your primary activities will generally include but not limited to data analysis, data trending, project and testing coordination, product and material specification management, inspection support, investigation leads, operational excellence leads, document revisions, initiating/completing quality systems, method/equipment validation and method projects activities.
Act as deviation/Lab investigation owners, support Out of Specification (OOS)/Atypical (AT) laboratory investigations. Provide impact assessment and help drive to closure in timely manner.
Collate and reports out third party lab performance metrics.
Provide analytical support to assigned products. Responsible for AR, APQR, regulatory filings, RTQs, etc of managed products.
Supports the financial oversight of third-party labs to assure budget requirements are met and is accountable for the CTL financial processes execution (ie. PO generation, invoice processing, etc.) of the Global OncESSM Quality Control unit.
Work with the Head of OncESSM QC, QC Business Operations Lead and QC Strategy and Business Operations to provide input on financial estimates and assumptions.
Develops testing plans and support method transfers as needed
Manage stability study protocol development, execution, data analysis and reporting for OpU products as designated
Constitute to data summary and communication tools such as dashboards, reports and product quality review.
Support continued business process improvement activities.
Cultivate and maintain relationships with key internal and external customers.
Initiate Change Controls to support change of vendor/TPIC specification documents, vendor test methods, stability protocols, and relevant site batch records.
Be a valued partner by providing actionable decision support (e.g. what-if scenarios for decision making).
Provide technical support to other QC activities as business needs arises.
Maintain training records current and GMP compliance when conducting Takeda business.
Education, Behavioural Competencies and Skills:
Bachelor’s Degree in Chemistry, Biology, or related scientific discipline.
Experience in in the pharmaceutical industry and/or QA/QC laboratory environment.
Must have good understanding of a variety of analytical techniques such as HPLC, dissolution, GC, FTIR, wet chemistry and other analytical techniques. Must have experience in analytical investigations, handling of OOS, OOT investigations.
Experience in API and oral solid dosage is a plus.
Experience in analytical laboratory, method execution, qualification and/or validation of small molecule or biologics assays.
Experience in regulatory support, authoring dossier sections, respond to regulatory inquires.
Strong communication and technical writing skills.
Cross functional and matrix management experience.
Awareness of financial processes.
Project management experience
General understanding of applicable regulations and guidance.
Strong proficiency in Microsoft tools, especially Word and Excel.
Knowledge of Laboratory Information Systems (LIMs).
Regulatory Understanding – general knowledge of regulations associated with manufacturing and packaging
WHAT TAKEDA CAN OFFER YOU
At Takeda, we are transforming the pharmaceutical industry through our R&D driven market leadership and being a values-led company. To do this, we empower our people to realise their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering Our People to Shine
Discover more at takedajobs.com
Job ID R0025166
Company: Takeda Pharmaceuticals
Company Location: Zürich, ZH