QA Manager (2 Jahre Befristung) — Roche

Full description

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position As a QA Manager (2-year term), you and your colleagues are responsible within QA Sterile Filling for ensuring that commercial products from the Sterile Filling Organisation’s prefabricated syringe line meet the specific requirements and that the approvals comply with both legal compliance in the customer markets and the internal Pharma Quality Standard (PQS) requirements. You are the expert for all quality-relevant questions and a link between bulk production and aseptic filling, laboratory, as well as other relevant interfaces.

Your area of responsibility includes the following responsibilities:

• Release of bulkware produced in Kaiseraugst taking into account all GMP and regulatory requirements, including Roche guidelines.
• Review and release of manufacturing regulations and Master Batch Records (MBR)
• QA responsibility as well as processing and assessment of deviations, CAPAs and changes as well as other GMP documents.
• Together with the Lean Production System team, advance methods and tools and live in daily business. Introducing and implementing ideas to improve the quality, efficiency of plants and processes as well as cost reduction.
• Close cooperation with internal and external interfaces to achieve our ambitious goals of lead time, quality, commitment and cost.
• QA Sterile Filling supports the Sterile Filling Organization with telephone piketting operations and is on site at Aseptic Process Simulation (Media Fill Filling) for qualification activities at the respective filling line.
• Introduction and assumption of new activities in neighbouring areas in the sense of a polyvalent further development, as well as creation and training of SOPs and QA topics
• Compliance with all safety and environmental regulations, as well as conscious promotion of operational safety.

Who are you You are a positive thinking, integrity and self-reflective personality with strong team skills and bring an open and quality-oriented attitude and mindset that is needed for successful work in your team and across departments. You trust yourself and others, take responsibility and live an open speak-up and error culture. Furthermore, you have the willingness to work in a self-organized team, with a high degree of personal responsibility in an open and collaborative environment. Your solution-oriented basic attitude and “can-do” attitude determines your daily actions. As a QA Manager You have successfully completed studies in the field of pharmacy, natural sciences, engineering or have an appropriate professional training, combined with several years of professional experience in the GMP field.

You also have the following competencies and skills

• Quick comprehension and great interest in technical processes as well as affinity in dealing with IT systems as well as routine handling of IT systems (e.g. Google applications and relevant GMP systems)
• Great willingness and curiosity to develop flexibly and to learn cross-divisionally in the sense of polyvalence. This includes an interest in capturing, getting to know and improving upstream and downstream process steps.
• A team-oriented mindset with a view to constantly improving processes and the ability to deliver consistent performance at a high level in a constantly changing environment.
• Knowledge and convinced commitment to process improvements (e.g. Lean Production System) as well as Agile Management are advantageous.
• Ability and openness to recognize and live the opportunities and benefits of change. In this sense, an interest in the areas of coaching and change management is advantageous as well as a strong communication ability.
• High level of teamwork and solution orientation as well as collaborative working methods as well as a pronounced service concept and customer focus
• Very good communication skills in word and writing in German and English.

Who we are A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an equal opportunity employer.

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