Specialist QA Process Parenterals

Specialist QA Process Parenterals - German Speaking

Location: Schaffhausen Switzerland - site based

Duration: 24 month contract

Hours: full time hours

Imagine your next project positively impacting patients' lives by ensuring high quality in our pharmaceutical products as part of a dynamic team responsible for Quality and Compliance guidance.

Specialist QA Process Parenterals (OI, DAP, Warehouses) As a Specialist in the QA Process Parenterals team you will join a dynamic team which is responsible for Quality and Compliance guidance, as well as Quality and Aseptic oversight of equipment and premises used for manufacturing in the Business Units Parenterals (compounding and subsequently filling of syringes and vials), Optical Inspection, Device Assembly and Packaging, and Warehouse departments at the Schaffhausen site. Due to the high number of ongoing projects combined with daily business activities, we are looking for a colleague who quickly can support the team with a focus on processes, equipment and projects in the Optical inspection (OI), Device Assembly and Packaging (DAP) and Warehouse departments.

roles and responsibilities.

• Provide Quality and Compliance guidance to OI, DAP and Warehouse departments and corresponding supporting departments

• Perform Quality oversight on the shop floor

• Actively contribute to new concepts and projects as well as suggestions for improvement

• Proactive risk mitigation

• Assess and approve Nonconformances and Corrections/ CPAs related to utilities, facility, environment, equipment and processes

• Review and approve Protocols, Reports, SOPs/WIs, Change requests (COCs) and other applicable documents

• Review and approve GMP critical SAP master data (e.g. manufacturing instructions)

• Support ‚customers‘ (Production, Quality Control, Logistics, MSAT, Engineering, etc.) in terms of GMP Compliance

how to succeed.

• You have a Bachelor’s or Master’s Degree in a technical or science field

• You have proven experience (minimum 3 yrs) in a GMP regulated Pharma production environment, or experience in a relevant Quality role (minimum 2 yrs)

• You have experience in at least one of the following areas and related processes

  • Optical inspection, e.g. fully automated, semi-automated and manual inspection (preferred)

  • Device Assembly and Packaging

  • Warehouse

• You are used to work in an GMP-environment, and have a genuine quality mindset which is shown in your daily work

• You know how to influence people and strive for a good working environment

• You are fluent in German and English

If you are a team-oriented, open-minded dynamic and highly motivated person with strong interpersonal skills you might be the one we are looking for. For collaboration with different departments, you will need flexibility, social competence, and a reasonable degree of authority. You will take decisions independently and provide advice as needed.

benefits.

This role offers a very competitive hourly rate. This contract will run for 24 month contract

you are welcome here.

Johnson & Johnson is 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.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Caring for the world … starting with the individual. This guiding principle inspires and unites the people at Johnson & Johnson. The culture of care is at the heart of our corporate philosophy, which is anchored in the Credo.

J&J Innovative Medicine (Cilag AG) is an international manufacturing company of Johnson & Johnson Innovative Medicine and produces pharmaceutical products as well as chemical active pharmaceutical ingredients (APIs) for global markets at its production site in Schaffhausen. Thanks to our innovative products, processes and technologies, J&J Innovative Medicine (Cilag AG) is today one of the leading pharmaceutical companies in Switzerland and at the same time a strategic site for launches and growth.

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 or LinkedIn InMail - you must apply direct to this advert.

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”.