At Johnson & Johnson, we believe health is everything.
Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.
Learn more at https://www.jnj.com
Job Function: Quality
Job Sub Function: Quality Assurance
Job Category: Professional
All Job Posting Locations: Schaffhausen, Switzerland
Job Description
About Innovative Medicine: 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. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
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.
MS Office, SAP, eLIMS, Comet, MES
Preferred:
* Experience in GMP environment, preferred but not limited to quality or operations
Other:
* Proficiency in German and English
* 100-80% working hours
Johnson & Johnson is committed to providing an inclusive interview process accommodating our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.
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