Quality Operations Specialist

Quality Operations Specialist

Location: Bern, Switzerland

Hours: 40h

Hybrid way of working, on-site 3 days per week 

Imagine your next role as a Quality Operations Specialist who will join Janssen Vaccines in Bern and will be responsible for overseeing processes and systems validation, ensuring compliance while supporting Quality Operations planning and KPIs.

Summary of the role:

Responsible for processes/systems/assays validation, support Quality Operations planning and KPIs, ensure compliance of operational / process documents/maintenance/calibration, ensure compliance of non-conformances and corrective/preventive action records, support site/organization objectives projects, proactively bring solutions/communicate within and out of Quality Operations, lead and support continuous improvement in alignment with Quality Principles, Credo and Leadership Imperatives, act as a back-up/deputy according to Quality Operations structure​. 

Key responsibilities: 

• Ensures that validated processes/systems/assays comply with regulations and standards

• Reviews and approves maintenance/calibration records / Equipment Qualification documents / Computer System Validation documentation / Data Integrity Documentation 

• Creates, reviews, and approves operational / process documents

• Delivers proactive Quality support to the site/organization considering timelines, cost reduction, and EHS&S

• Supports Audits and Inspections on-site

• Support Data Integrity Site SME

• Stakeholder management 

how to succeed:

• Degree in pharmacy, sciences, engineering, or equivalent

• Proven working experience in a GMP environment, preferably in Quality 

• Knowledge in GMP

• Knowledge in Validation / Qualification

• Knowledge of CSV/Data Integrity

• English fluent, (German is a plus) 

• Decision-making ability and customer orientation 

• Knowledge of biological manufacturing processes

• Knowledge of Project Management

benefits

This role offers a competitive hourly rate & a supportive working environment. The role will run for a year and the first contract is until 31/12/2024. 

About Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

https://www.jnj.ch/

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. 

questions

If you would like some additional information about the role please contact:  katerina.alikaridou@randstadsourceright.nl

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 are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each 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”.