Quality assistant Jobs in Winterthur

We are looking for a DP Lead parenteral Iron, to join our team in Zurich or St. Gallen, Switzerland. As part of the Integrated Product Team Iron & Small Molecules within Technical Operations, you will be responsible the scoping and execution of technical work packages related to CMC Development, Continuous improvement, and Technology Transfer of parenteral pharmaceutical products and manufacturing processes, as well as providing continuous MS&T support to external partners and CMOs to support routine manufacturing operations. The main focus will be on our iron-based parenteral products.

Key Responsibilities

• Scoping of technical work packages for different types of projects (e.g. CMC Development, Tech Transfer, Continuous Improvement) by defining technical implementation strategies, deliverables and technical risks

• Contribute to and review project execution plans (e.g. technical transfer plans)

• Execute DP related project work packages and tasks as subject matter expert for aseptic and terminally sterilized parenteral products manufacturing as per the project plan

• Proactively engage in periodic cross functional calls and meetings with internal and external team members

• Prepare regular status updates on assigned work packages and tasks as part of regular project reporting and stakeholder management

• Serve as a key technical contact for external partners and CMOs for assigned projects as well as for defined topics in routine manufacturing (including coordination and support in case of technical issues, process changes, major deviations, and improvement initiatives)

• Serve as a key subject matter expert for internal stakeholders (e.g. perform Change Control impact assessments and support quality event investigations)

• Support the evaluation of alternative, cost-effective sourcing strategies for related products as technical SME, including attending technical due diligence visits at potential future CMOs

• Visit of CMOs to oversee technical implementation and troubleshoot as needed

• Provide adequate background information, documentation, and technical advice to decision bodies and negotiation teams to ensure timely decision-making

• Compile and review respective technical documentation

• Proactively engage with CMOs to identify and assess potential to improve quality, compliance and cost efficiency of established processes. Contribute to the establishing of business cases and decision-making processes on implementation of change

Skills & Experience

Minimum Requirements

• Qualification in natural/life sciences or associated engineering degree (i.e. Biology, Biochemistry, Chemistry, Pharmaceutics, etc.), Bachelor/Master level or equivalent

• Minimum 5 years experience in the pharmaceutical industry, direct experience in full scale commercial manufacturing (compounding, aseptic filling, sterilization, CCIT/Visual inspection) of parenteral products for intravenous application

• Self-driven and fast learner with the ability to take ownership execute work packages and tasks independently in a matrix organization

• Confident and proactive team player who collaborates effectively while working autonomously.

• Solid expert knowledge in sterile and aseptic fill & finish CMC development, Equipment -/Process Qualification & Validation, Manufacturing

• High Flexibility and willingness to travel & Experience in External Manufacturing Environment

Preferred Requirements

• Familiarity with GMP requirements and Guidelines related CMC LCM activities, including Annex 1

• Preferably, experience with non-transparent solutions

• Know-how across various parenteral product primary packaging solutions (vials, ampoules, infusion bags)

• Experience in other Drug Product and Finished Product manufacturing & Technology Transfer, e.g. oral solid dosage forms

• Ability to work effectively in a multicultural and international environment

• Strong communication skills

• Analytical thinking & problem-solving skills

• Ability to adapt to changing project requirements.

• Languages: English fluently, German is an advantage

Are you interested? We are looking forward to your online application.

About CSL Vifor

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care). The parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

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At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.