Quality Assurance Expert - Engineering / Validation

By 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’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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.

QA Expert:

• Act as QA(Quality Assurance) representative for both routine GMP (Good Manufacturing Practice) activities and Takeda projects.

• Act as the Quality partner within Production Unit Team and the Quality Control laboratories, Warehouse and Engineering/Maintenance/Validation departments as applicable.

• Ensure quality of information within systems and documentation in respect to current guidelines, compliance and regulatory requirements.

• Support and work in line with the “QA on the shopfloor” requirements (for example through GMP audits or events management).

• Responsible for quality aspects during the validation activities (routine and projects).

• Shall promote and be involved in Continuous Improvement.

• Understand and apply Takeda EHS (Environment, Health, Safety) guidelines and commitments policy, take care of its own safety, report risk situations and improvement opportunities to supervisory personnel.

Deviations:

• Lead or approve “deviations” with in line with to standard procedures and regulatory requirements.

• Support all investigations (intersites and all kind of criticity of deviations) related to deviations process and in the area of responsibility.

• Ensure maintenance anomalies are reviewed and approved and escalate to deviation accordingly.

Change controls:

• Review and evaluate internal change requests or interfacility changes (IFCAs) according to procedures, GMP requirements and licenses.

• Follow the activities associated to the significant changes.

Compliance/Quality oversight:

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

• Act as an SME (Subject Matter Expert) for the QA.

• Participate in internal or external assessments in the respective area, as required.

• Provide feedback on projects and routine activities using proactive communication.

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

• Ensure a straight collaboration with other QA.

• Active participation in regulatory agency inspection and internal audits, closure of observations /audit items and regulatory submissions.

Validation activities:

• Ensure the review and approval of validation document (protocols, reports, procedures master documents, URS, DRDQ) in timely manner.

• Evaluate and approve deviations related to validation protocols (description, investigation and identification of corrective actions).

• Define and challenge validation approaches to be compliant with current regulations.

• At least 2 years of experience in an GMP environment.

• University degree in Engineering, Biotechnology, Pharmacy, and Quality Management applied to industrial process or equivalent experience in pharmaceutical and /or biotechnological companies.

• French fluent; English read written and spoken.

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

• Good knowledge of FDA, EMA, ICH regulations, Pharmacopeias and Quality System standards.

• Knowledgeable in auditing and inspection against regulatory / Quality standards.

• Knowledge/experience with Quality tools such as Trackwise.

• Good analytical skills and ability to simplify the complex.

• Solution oriented and team spirit.

• Good listener ad communication skills.

• Good organizational skills and continuous improvement mindset.

- 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.