Quality Specialist

Quality Specialist

Location: Switzerland Remote (25% travel within Switzerland)

Duration: Hours: 40h    

Imagine your next role as a Quality Specialist working for Janssen

Job Summary:

Provide QA oversight support for External Manufacturer, based in Switzerland. Contribute to the ongoing technology transfers, inspection readiness, implementation, and execution of quality systems in support of the external manufacture of pharmaceutical large molecules (Fill-Finish activities).

Support the External Quality account owner on tech transfers/projects as appropriate.

Requires solid knowledge in all quality systems concerning the manufacture of drug products and extensive knowledge of Quality Assurance, Quality Control and Compliance.

Requires travel to the External Manufacturer site to provide cGMP assistance and quality oversight.

Responsibilities:

• Serve as a contact point within the QA organization of other departments of both Janssen and the external manufacturer with respect to quality relevant subjects. Build relationships and influence external partners to continuously enhance quality culture and business excellence.

• Perform review of equipment and facility qualification, environmental monitoring, technical documents, raw material specifications, analytical methods, and master batch records to ensure products and processes comply with cGMP requirements.

• Provide QA support for technology transfer and improvement of existing manufacturing processes

• Following successful tech transfer, support day-to-day quality oversight for production activities, including identification of risks, deviation and CAPA management, Complaint handling, change control, and batch documentation review.

• Ensure that all relevant QA related concerns at the external manufacturer’s sites are raised to the External Quality Account Owner.

• Ensure the timely supply of Product Quality Reports (PQRs) from the external manufacturer according to schedule. Carry out a documented review of PQRs

• Apply applicable GMP regulations international requirements to all aspects of the position.

• Support regulatory inspection readiness at the external manufacturer for Janssen products.

• Monitor trends, identify issues, recommend, and implement appropriate actions

To be successful in this role you have:

• Bachelor’s Degree with a concentration in engineering, science, or an equivalent technical discipline

• Solid (> 5 y) knowledge of GMP, specifically:

• Aseptic manufacture (sterile, liquid dosage forms products and/or Large Molecule) experience is preferred (QA and/or production). 

• Able to connect easily, team worker, able to manage across cultures.

• Able to work independently while managing stakeholders, to handle complexity, and to take ownership for deliverables, as well as flexibility and confirmed collaboration skills, are required

• Able to think outside the box and come up with solutions to problems. Open-minded for new ideas and willing to pivot when necessary.

• Strong interpersonal and written/oral communication skills

• Advanced degrees are a plus and may reduce the experience required

• Proficiency in English is a must

• Located in Switzerland (In or nearby Canton of Valais)

• Will require travel to the external Manufacturer

benefits

This role offers a very competitive hourly rate & a supportive working environment. 

you are welcome here

Janssen is an innovative pharmaceutical company: we work daily on the frontline of health innovation. We can only meet this challenge because of our talented employees. Working at Janssen means that you get every opportunity to develop your career optimally.

about Janssen 

Janssen is the Pharmaceutical Company of Johnson & Johnson - the world's most comprehensive and broadly-based healthcare Company. At Janssen, we bring together top scientists and researchers to pursue the most promising science and drive collaboration to create visionary medicines and healthcare solutions covering five priority therapeutic areas - Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, and Oncology. Contribute to the next pharmaceutical breakthrough with your next project at Janssen. 

https://www.janssen.com/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in the Netherlands are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!