Product Quality Expert
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As Product Quality Expert (PQE) you will report directly to the Head of Quality Compliance & Systems and be responsible for compliance/regulatory activities related to biologic products.
The PQE is the representative for different responsibilities, including: Regulatory Compliance activities, Interaction with Authorities, External inspections and internal audits, Quality projects.
Regulatory compliance:
Be responsible for biological product manufactured on site and act as an expert for all the topics related to regulatory compliance for this product.
Prepare Product Quality Reviews (PQR) for products manufactured at the Neuchâtel facility, annually and according to health authority requirements.
Review global release specifications, ensuring the implementation of correct updated versions for products manufactured at Neuchâtel facility.
Participate in GMP (Good Manufacturing Practice) tours of facility to ensure inspection ready status.
Interaction with authorities:
Act as a “Subject Matter Expert” (SME) in the creation and modification of regulatory license sections for products manufactured in Neuchâtel (clinical phase III and commercial).
Manage/prepare the necessary supportive documentation for regulatory submissions and for major change projects in Neuchâtel facility.
Prepare/Review documentation for change controls, audit observations and regulatory agency questions.
Support/Write the responses to regulatory agency questions, and if necessary, facilitate the collaboration among several Subject Matter Experts to achieve the required documentation.
External inspections and internal audits (corporate):
Supports the preparation of the inspections.
Supports the preparation of pre-required documents.
Participates in audits and inspections as required (back room or inspection room).
As part of the quality matrix team, helps to define of the strategy of responses to health authority questions.
Updates all records relative to the inspection in TrackWise when necessary.
Proposes improvement initiatives to simplify and streamline the tasks described above.
Routine and Quality Projects:
Assist in preparation and review of all quality documentation as required.
Participate in Quality Council meetings as necessary.
Support the coordination of site Key Performance Indicators (KPIs).
Participate in project teams when necessary.
Participate in product launch activities.
Identify opportunities to improve quality processes.
Collaborate with the global Quality Product Leads and Regulatory Affairs partners.
University degree in technical/ scientific discipline such as biochemistry, chemistry, engineering or equivalent
At least 3-5 years of experience with manufacturing in the biotechnology and/or pharmaceutical industry
Experience in writing and/or reviewing eCTD licenses (quality - module 3) is an asset
Experience with the regulatory affairs framework is an asset
Knowledge of FDA, EMA, ICH, Pharmacopoeia regulations, Quality system standards and data integrity principles
Experience as a change owner or project leader
Knowledgeable in GMP inspections and management of regulatory / quality standards
Fluent in English, and French
Knowledge/Experience with quality tools such as Trackwise, Veeva, eCTD viewer
Good analytical skills and ability to simplify the complex
Problem solving oriented
- Competitive salaries.
- Full accident coverage.
- Participation in health insurance premiums.
- Advantageous pension plans.
- Subsidised meals.
- Financial participation in employee sports activities.
- Transport: support for local public transport passes, free parking, car sharing programme.
- Takeda Neuchâtel offers its employees an attractive working environment and conditions. The well-being, safety, development and career advancement of its employees are at the heart of our vision and our Human Resources, Health, Environment and Safety policies.
- Takeda Neuchâtel is an employer committed to its employees and to future generations.
With over 700 employees, Takeda Neuchâtel is one of the ten largest employers in the Canton of Neuchâtel and one of the leading biopharmaceutical production sites in Switzerland. Operating 24 hours a day, 7 days a week, the site employs a wide range of professionals trained in biotechnologies and their application in industrial production.
With more than twenty nationalities, Takeda Neuchâtel offers an international, diverse and innovative working environment within a company that is firmly rooted and committed to its local ecosystem.
Takeda Neuchâtel is certified as a training company by the Swiss State Secretariat for Economic Affairs. We train young apprentices in various fields such as laboratory quality control, logistics, IT and biopharmaceutical production.
Takeda is proud of its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and job applicants without regard to skin colour, religion, gender, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law.
