2 x Local Quality Owner Launch
Vor 2 Tagen
We manufacture high quality pharmaceutical drug products (Small and Large Molecules) and active pharmaceutical ingredients (APIs). Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all major global markets. The Schaffhausen facility is a center for launching and boosting growth in parenterals, having an impressive pipeline of new and innovative products.
Position summaryThe function holder is responsible for the QA oversight of a selected Portfolio of (Combination-) Products for parenteral New Product Introductions (NPI) manufactured at the J&J IM Schaffhausen site.
Principal responsibilities- Key Contact for internal and external stakeholders (operations, planning, logistics, engineering, etc.) within cross-functional teams in terms of Quality and Compliance.
- Q&C contributions including Decision making and problem solving and oversight of assigned qualifications and validations of NPI running on new manufacturing lines
- Investigation lead for major non-conformances (deviations) including CPA alignment with Operations counterparts
- In-time release of parenteral products (intermediate and finished products)
- Proactive risk mitigation
- Review and approval of non-conformances (deviations) records and change control requests
- Review and approval of GMP critical SAP master data (e. g. bill of material, manufacturing instructions etc.)
- Review and approval of work instructions and standard operating procedures
- Support of cross-functional and global projects
- Review of Annual Product Reviews
- A minimum of a Bachelor’s degree, preferably in a technical/scientific field. A Master’s degree or advanced is desirable.
- Minimum of 5 years of experience in a GMP regulated Pharma production environment or in a relevant quality or supply chain role.
- Strong understanding of parenteral fill/finish manufacturing incl. device assembly and packaging processes.
- In-depth knowledge in GMP standards, policies and procedures
- Knowledge about regulatory guidelines preferred
- Advanced communication skills, verbal and written in both English and German
We are looking for a dynamic and solution-oriented individual eager to contribute to our team and drive success in a collaborative, international and fast-paced environment. If you see yourself in this role, we encourage you to share your application materials with us without hesitation.
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.
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.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges.
We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong-
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