Quality Assurance Expert

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Job Description

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, the QA Expert is responsible for compliance and quality oversight related to activities throughout the beginning of Takeda Neuchatel value stream process covering supplier quality management, supply chain & warehouse processes.

How you will contribute:

Supplier Quality Management

• Lead the execution of supplier qualification, maintenance, and monitoring.

• Manage Supplier Notifications of Change (SNC), Quality Agreements, and supplier assessments including deviations and corrective actions

• Oversee supplier monitoring, Supplier Action Requests (SAR), and new supplier requests (NSR).

• Participate in on-site projects and conduct gap assessments

• Participation in local GMP audits and external supplier audits

Release activities

• Inspection and Release of raw material and external BDS

• Ensure Release planning is up to date

• Follow up on KPI of release of raw materials

• Ensure activities associated with the archiving as required

Compliance/Quality oversight

• Act as the Quality partner for QC Laboratory / Warehouse Department

• Execute Takeda guidelines and Regulatory cGMP requirements in the respective Quality area

• Acts as Quality Representative in both routine and Takeda facility projects to support the quality system deployment and application in order to meet the current Regulatory Requirements

• Provide feedback on projects and routine activities using proactive communication

• Execute the Takeda internal facility GMP-Tour and participate to external audits as required

• Support for regulatory agency inspection and internal audits, closure of observations/audit items and regulatory submissions

Deviations

• Assess the deviations in term of acceptability to standard procedures and regulatory requirements

• Support all investigations related to CAPA process and complaint in the area of responsibility

Change Controls

• Review and evaluate internal change requests, interfacility changes (IFCA) or external changes from suppliers (SNC) according to procedures, GMP requirements and licenses

• Follow the activities associated to the significant material changes

• Review and evaluate Material Qualification for chemicals

• Review and evaluate Transportation Qualification for NE site

Documentation

• Prepare, evaluate and approve new or revised documents (procedures/forms/specification etc)

• Ensure timely review and implementation of documentation for accuracy and compliance

• Propose continuous improvement of documentation in direct partnership with partners

What you bring to Takeda:

• University degree in Engineering, Biotechnology, Pharmacy and Quality Managemenet

• Fluent in English and French (C1 level)

• GMP Audit Experience

• High affinity to digital technology

• Demonstrate the Takeda Values of Integrity, Fairness, Honesty, Perserverence as a natural way of working.

• Good knowledge of FDA, EMA, ICH regulations, Pharmacopeias and ISO Quality system standards

• Execute the strategic direction and oversight pertaining to external auditing and supplier quality and material management to achieve sustained success for regulatory inspections and supply chain product quality

• Ensure compliance with the global audit and specification policies, guidance, standards, procedures governing Quality Auditing and Supplier Quality

• Execute the Supplier Qualification program requirements per schedule

• Good listener and communication skills

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.

LocationsCHE - Neuchatel

Worker TypeEmployee

Worker Sub-TypeRegular

Time TypeFull time