- The person in this function provides support to the management of the local pharmaceutical quality system at the sites as well as supports process improvements for the quality systems.
- Additionally, provides technical and administrative support to the Quality Operations group in relation with daily activities.
- This includes documentation management, extraction and preparation of reports, training coordination, user access management for IT Quality systems, management of the Archive room etc.
Description of Activities:
- Provide support for the sites in IT Quality systems (non-conformity management, electronic documentation management, product lifecycle management).
- Be a qualified trainer for the Sites in Exceptions, Investigations, Change Control workflows.
- Act as administrator and super user for those systems: maintain user accesses current, in relation with employees’ current position and training status; provide system support to the site
- Act as Quality Operations training coordinator, ensuring that employees working on regulated activities have training profiles consistent with their function, and that the training status of such employees complies with objectives. Report on such activities
- Support preparation of regulatory inspections and internal inspections lead by Corporate Quality that occur at the sites
- Support to routine quality meetings preparation (routine local Quality Management Review meetings etc.)
- Participate in local and global projects for process and systems improvements.
- Support management of the PO&T archive room including archiving, destruction, periodic reviews and shipping process to permanent archive facilities
- Management of workflows in the electronic documentation management system and monitoring the Contract Manufacturers performance evaluations on time completion
- Minimum 1- 2 years’ experience working in regulated industry such as pharmaceutical, biotechnology, medical device or food industry
- Highly motivated, able to work independently as well as part of a team
- Ability to prioritize and drive for results
- Good communication skills
- Fluent English (written and spoken) is a must
- Our company is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases.
- Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
- Our company is one of the world’s oldest independent biotechnology companies.
- Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options.
- These include programs for Alzheimer’s Disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, spinal muscular atrophy and neuropathic pain amongst others.
- With more than 7,000 people worldwide, our company is truly a global organization.
- Our international operations are based in Switzerland and we have world-class manufacturing facilities .
- We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
- All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law.
Job Segment: Biotech, Quality Manager, Pharmaceutical, Science, Quality, Research