Product Quality Expert
vor 1 Monat
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. What you bring to Takeda : 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 What Takeda offers you : - 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. Learn more about Takeda Neuchâtel : 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. "Empowering our people to shine” : 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. Locations CHE - Neuchatel Worker Type Employee Worker Sub-Type Regular Time Type Full time
-
Product Quality Expert
vor 1 Monat
Neuchâtel, Schweiz Takeda VollzeitDescription About the role: 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...
-
Product Quality Expert
vor 3 Wochen
Neuchâtel, Schweiz Takeda VollzeitDescription About the role: 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...
-
Product Quality Expert
vor 1 Monat
NEUCHÂTEL, Schweiz Takeda Pharmaceutical VollzeitBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
-
Product Quality Expert
vor 3 Wochen
NEUCHÂTEL, Schweiz Takeda Pharmaceutical VollzeitBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
-
Quality Systems Expert
vor 4 Wochen
Neuchâtel, Schweiz Takeda VollzeitDescription About the role: The Quality System Expert is responsible for supporting the Quality Systems group from an Administrator/Subject Matter Expert (SME) standpoint in accordance with Takeda policies, standards, procedures and Global cGMP. The Quality Systems Expert insures that new or modified Quality Systems (Deviation, CAPA, Change...
-
Quality Systems Expert
vor 3 Wochen
Neuchâtel, Schweiz Takeda VollzeitDescription About the role: The Quality System Expert is responsible for supporting the Quality Systems group from an Administrator/Subject Matter Expert (SME) standpoint in accordance with Takeda policies, standards, procedures and Global cGMP. The Quality Systems Expert insures that new or modified Quality Systems (Deviation, CAPA, Change...
-
Quality Systems Expert
vor 4 Wochen
NEUCHÂTEL, Schweiz Takeda Pharmaceutical VollzeitBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
-
Quality Systems Expert
vor 3 Wochen
NEUCHÂTEL, Schweiz Takeda Pharmaceutical VollzeitBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
-
Quality Assurance Expert
vor 1 Monat
Neuchâtel, Schweiz Takeda VollzeitDescription About the role : This position is within the Quality organization at the Neuchâtel facility and is intended for the Quality Assurance department. Within this position, QA Expert is responsible for Quality Assurance in the frame of activities all along the manufacturing and release process. How you will contribute: QA...
-
Quality Assurance Expert
vor 3 Wochen
Neuchâtel, Schweiz Takeda VollzeitDescription About the role : This position is within the Quality organization at the Neuchâtel facility and is intended for the Quality Assurance department. Within this position, QA Expert is responsible for Quality Assurance in the frame of activities all along the manufacturing and release process. How you will contribute: QA...
-
Quality Assurance Expert
vor 1 Monat
NEUCHÂTEL, Schweiz Takeda Pharmaceutical VollzeitBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
-
Quality Assurance Expert
vor 3 Wochen
NEUCHÂTEL, Schweiz Takeda Pharmaceutical VollzeitBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
-
QA Engineering/Validation Expert
vor 4 Wochen
Neuchâtel, Schweiz Randstad VollzeitJobdescriptionFor ourclient, an international pharmaceutical company based in Neuchatel,we are looking for a QA Engineering/Validation Expert.BackgroundTheobjective of this resource within the Quality Ops organization isto provide support as a Quality Assurance Expert in the frame ofroutine GMP operations. He/she must ensure the quality ofinformation...
-
Quality Assurance Expert
vor 4 Wochen
Neuchâtel, Schweiz Takeda Pharmaceutical VollzeitBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
-
Quality Assurance Expert
vor 3 Wochen
Neuchâtel, Schweiz Takeda Pharmaceutical VollzeitBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
-
Head of Quality Control Operations
vor 1 Monat
Neuchâtel, Schweiz Takeda VollzeitDescription About the role: We're excited to offer a unique opportunity for a Head of Quality Control Operations at our biological site in Neuchâtel. This role entails overseeing the Quality Control Laboratories (Microbiology, Biochemistry, Lab Support, and Quality Sterility Assurance) within a large-scale plant. Additionally, you'll...
-
Head of Quality Control Operations
vor 3 Wochen
Neuchâtel, Schweiz Takeda VollzeitDescription About the role: We're excited to offer a unique opportunity for a Head of Quality Control Operations at our biological site in Neuchâtel. This role entails overseeing the Quality Control Laboratories (Microbiology, Biochemistry, Lab Support, and Quality Sterility Assurance) within a large-scale plant. Additionally, you'll...
-
Engineer Field Quality Warranty
vor 2 Monaten
Neuchâtel, Schweiz Freudenberg VollzeitWorking at Freudenberg: We will wow your world! Responsibilities: Analyse of field parts Implementation and following Customer requirements in regards of field part investigation Collecting information and data´s for warranty cost negotiation Observation of product quality field Manage and driving continuous improvement programs field quality...
-
Engineer Field Quality Warranty
vor 3 Wochen
Neuchâtel, Schweiz Freudenberg VollzeitWorking at Freudenberg: We will wow your world! Responsibilities: Analyse of field parts Implementation and following Customer requirements in regards of field part investigation Collecting information and data´s for warranty cost negotiation Observation of product quality field Manage and driving continuous improvement programs field quality...
-
Head of Quality Control Operations
vor 1 Monat
NEUCHÂTEL, Schweiz Takeda Pharmaceutical VollzeitBy clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...
