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Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
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We are searching for the best talent for QA Specialist (Synthetics Manufacturing) to be in Schaffhausen .
Purpose:
We are excited to announce an opening for a Quality Specialist in our Quality Assurance Synthetics Manufacturing team. This dedicated team plays a vital role in ensuring the highest standards of quality, security, and efficacy for our Active Pharmaceutical Ingredients (APIs) and solid dosage forms manufactured within our Business Unit.
In this key position, you will help ensure that our products are delivered to our patients reliably and on time. If you are passionate about quality assurance and want to make a difference in the lives of others, we invite you to apply and be part of our mission!
You will be responsible for :
Performing batch record reviews and coordinating batch release activities for corresponding Synthetics Manufacturing products
- Ensure timely batch release in consultation with Quality, Regulatory, Planning, Production and Quality Control
- Usage decision for raw materials and final products
- Timely assessing and processing of Q-relevant SAP master data and workflows
- Review and processing of documents (SOPs, WIs, FRMs) in the work area
- Editing, review and approval of documents in TruVault.
- QA support for projects
- Administrative activities (record retention, technical documents, batch access, IT orders, etc.)
- Supporting Quality Oversight activities
- Ensures inspection readiness
- Participates in audits and inspections
Qualifications / Requirements
Required:
- Completed studies in the natural sciences or technical field, master school or higher specialized training, or equivalent professional experience (2-3 years in the pharmaceutical field)
- A strong sense of quality and responsibility
- Excellent verbal and written communication skills in German and English, including the ability to communicate optimally with internal and external customers.
- Good digital literacy, e.g. MS Office, SAP, eLIMS, Comet,MES
- Independent working style and resilience required to take care of the challenges as a QA Specialist Batch Certification
Preferred:
- Experience in GMP environment, preferred but not limited quality or operations
Other:
- Proficiency in German and English
- 100-80% working hours
At Johnson & Johnson, we are committed to providing a hiring process that is thorough, transparent, and fair. The process starts with a careful review of your CV, and if selected, this is followed by an initial conversation with a member of our recruitment team. If you move forward at this stage, you will participate in interviews with at least two hiring managers across two separate sessions. While the interview process may evolve at times, our recruitment team will ensure that you are kept informed and will work diligently to manage timelines and expectations clearly. After a hiring decision has been made, successful candidates will need to complete the necessary country-specific due diligence.
Finally, we genuinely value your feedback and will invite you to complete a brief survey at the end of the process to help us improve our practices. Thank you for considering a career with us; we appreciate your interest! #RPOAMS
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