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As a leading university hospital with a rich tradition, the Inselspital is part of the Insel Group and is a centre of medical expertise and high technology with an international reputation as well as being a first-class training and research centre.

QA Manager Operations

SWAN Isotopen
100 %
Entry as soon as possible
SWAN Isotopen AG is a fully certified modern radiopharmaceutical company (30 employees) on the Campus of Inselspital, the University Hospital Bern. We are producing radiopharmaceuticals for diagnostic and for therapeutics purposes for application in nuclear medicine.

To strengthen our QA Department we are looking for a highly motivated team member. A professional and committed team is waiting for you in a fascinating working environment, which combines the production of commercial radiopharmaceuticals and development of new products. Your key role is to contribute to all steps of the quality management process on innovative radiopharmaceuticals.
Job description
  • Coordination of the Quality Associates team (QC and PRD) who themselves are responsible for specific functions according to their job descriptions. Through your expertise, you are able to organize, take decisions and escalate situations to ensure the compliance of the manufacturing activities are guaranteed
  • Work in the field, having an oversight over the manufacturing operations from a quality point of view
  • Participation in the root cause analysis and corrective actions for product and process related non-conformances
  • Review, perform revision and approve Standard Operating Procedures (SOP)
  • Data collection for metrics and identification of negative trends and you support the QA and regulatory affairs units for audits and inspections
  • Review and complete batch records and related documentation
  • Support QA in control of qualification and calibration status of plant equipment
  • Definition and maintaining company policies for quality system, environmental and health safety, documentation and personal protective requirements
Qualifications/Requirements
  • Education: MSc degree in Chemistry, Biochemistry, Pharmaceutical sciences
  • Minimum of 5 years of GMP experience in a QA position in a pharmaceutical industry
  • Ability to work effectively in a team as well as independently
  • You have ideally a first experience managing a team directly or indirectly
  • Reliable team player, able to work under time pressure
  • Language: English (understand oral/written), German is an asset

Additional information
As QA Manager Operations, you are responsible that all manufacturing procedures meet or exceed cGMP regulations. You collaborate with the daily manufacturing- and facility operations from a quality perspective, facilitating activities related to the quality of finished radiopharmaceutical. The job position implies a close collaboration with the manufacturing team; reactive support of discrepancy identification; effective resolutions; root cause analyses and corrective actions for product and process related non-conformities. You will work with the Quality Assurance Associates but in addition coordinate and manage the activities of the team. Through your level of expertise, you are able to drive improvement projects.
You will report to the Head of Quality and work cross-functional with different quality units (QC, QA).
What you can expect
We offer contemporary working conditions in an international and multicultural team, which operates in a modern, state of the art infrastructure and stimulating working environment.
Are you interested?

Contact

For further information, please contact
Main phone +41 31 384 00 40

Your application

Please only apply online.

The Insel Group

The Insel Group forms Switzerland's largest full-service medical care system -– from primary care through to state-of-the-art medicine -– that is available to everyone in the country. This ensures that every patient is treated at the most appropriate place for them and has access to the latest technologies, methods and medical options at all times.
Gebäude
Inselspital, Universitätsspital Bern
Freiburgstrasse, CH-3010 Bern
Schweiz
As a university hospital and the leading training institution in Canton Bern, the Inselspital offers training in 36 out of 44 possible medical disciplines. In their role as training organisations, the university clinics and institutes of the Insel Group are rated with an "A" – the highest classification.
In addition, the Insel Group offers practical training and CPD (continuous professional development) for all health professions up to specialist nursing care. It offers a broad range of vocational traineeships for its trainees, who currently number 300.
We are keen to foster personal development among our staff. Career opportunities and relevant models are transparent; CPD is provided with generous support.
Gender equality and the advancement of women are a big priority for us. Our career paths and models are designed so that part-time work and family responsibilities are no obstacles to taking on responsibility at our company.
Flexible working hours, part-time work and job-sharing. We are keen to accommodate the needs of our staff where the role and operating requirements of the hospital allow. This also applies to our executive-grade roles.
We offer 115 childcare places for around 180 children up to pre-school age at various locations. At the Inselspital site, there is also a group for babies from the fourth month and a private kindergarten.
As a family-friendly employer, the Insel Group provides generous schemes for unpaid leave, short remunerated breaks and parental leave in the event of the birth of a child or an adoption. Fathers also receive 15 working days paid paternity leave. Extra days of leave are offered by way of a loyalty bonus from as early as the fifth year of service!
Bern and its region assume a central role in Switzerland. With its enviable infrastructure, rapid links to the country's major conurbations, proximity to urban and rural districts and variety of wonderful recreational areas, Bern and its environs offer an unusually high quality of life.
The social package we offer is far above the industry average. Our benefits are exceptional, particularly in the case of maternity leave, continued payment of salary in the event of sickness and accident, and full payment of daily sickness allowance or group health insurance premiums.
We provide medical excellence with a human touch and respect for one another. As a big business we create a unique family atmosphere through meaningful diversity within the Insel Group.
For us it is very important new employees undergo a well prepared and thorough induction. We give you detailed information about your new employer at a monthly welcome event and also provide tailored induction programmes in the clinics, institutes and administrative departments.
Every site operated by the Insel Group has one or more staff restaurants. Our staff appreciate the quality, variety and creativity of our catering, which has repeatedly won prestigious gastronomy prizes.
Innovations in medicine and research are only possible if we continue to develop. Rapid developments in the medical field bring about extraordinary processes of change – as well as prospects for individual development for you.
Humanity

Humanity

Respect and a high regard for the individual are central to everything we do.

Competence

Competence

We have confidence in our abilitiesand share our knowledge for the benefit of all our patients.

Quality

Quality

Our actions comply with the highest standards of quality and safety.

Innovation

Innovation

We seek new approaches as well as promote research and innovation.

Cooperation

Cooperation

We treat one another with respect and appreciation, foster professional cooperation and promote interdisciplinarity.

Integrity

Integrity

We are committed to our values and are guided by sincerity, transparency and dependability.

Facts

Facts and figures

  • 6 sites in the canton of Bern
  • Over 10,000 employees from around 80 countries
  • Over 300 trainees in 16 vocational fields
  • 15,185 placement/training weeks (at tertiary level, medical and other professions)
  • Around 500,000 patients, including over 60,750 inpatients
  • 1st class: the Inselspital is the leading Swiss university hospital in terms of patient satisfaction.
Facts and figures
University hospital (highly specialist care, all disciplines) University hospital (highly specialist care, all disciplines)
City hospital Tiefenau (comprehensive primary care and secondary care) City hospital Tiefenau (comprehensive primary care and secondary care)
Rural hospitals (primary care close to home) Rural hospitals (primary care close to home)
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