Quality System Specialist in Bern

veröffentlicht
Kontakt
Audrey Bisch, Basel Professionals Health Care & Life Sciences
Jobtyp
Contract
jetzt bewerben

job details

veröffentlicht
Ort
Bern
Sektor
Life Sciences
Jobtyp
Contract
Referenznummer
16002
Kontakt
Audrey Bisch, Basel Professionals Health Care & Life Sciences
Telefon
058 201 55 50

Stellenbeschreibung

For one of our client, a big pharmaceutical company in Bern, we are currently looking for a Quality System SpecialistPosition overviewThe Quality Systems Specialist position aim to ensure that the Health Authorities regulations,  standards/procedures and local QMS requirements are applied in the local procedures by supporting the Document Owners in defining and writing their processes in compliance with Good Documentation Practices.Tasks & Responsibilities:• Review and approves routine incoming process documents assuring compliance with the current Quality Management Systems requirements as defined in the local Quality Manual• Mentor Document Owners in defining their processes, suggesting processes improvements/KPIs and writing a compliant documentation assuring Good Documentation Practices• Monitor regulatory standards updates, translating them into the quality processes.• Contribute to the creation and maintenance of documentation and records for area of responsibility - may include Standard Operating Procedures (SOPs), Work Instructions (WIs), and other quality documentation.• Perform Quality Investigations and handle Change Controls Qualifications & Experience• University degree in Natural Science, Medicine or Pharmacy• Profound knowledge of cGMP regulations and Quality Systems processes especially Nonconformances, Change Controls, Documentation Management and Training• 3 – 5 years working experience in a GMP environment, preferably in Quality• English Fluent a requisite• A very good level of German is needed because part of the documentation is in German• Statistics techniques knowledge is preferable• Strong written, oral, and presentation skills.• Ability to work in a matrix environment where priorities change rapidly, and tight deadlines exist.• Excellent communication skills, stakeholder management skills and proactivity.This is for a one year contract starting in July 2021. It can lead in time to apermanent position.