Biochemist (m/f/d)
vor 1 Monat
Get started now as Quality Officer Drug Product ( m/f/d)
We are currently looking for a Quality Officer Drug Product ( m/f/d) on behalf of our business partner in the pharmaceutical industry based in Biberach .
Apply today and start your new job tomorrow Applications from people with disabilities are of course welcome.
Here's what we offer
Attractive salary and long-term job security through group affiliation Up to 30 days vacation per year Contribution to company pension scheme after end of probationary period Extensive social benefits, including Christmas and vacation bonuses Reimbursement of travel expenses As a rule, a permanent employment contract Good chances of being taken on by our business partners Tailored further training opportunities and free language courses A wide range of employee benefits
Your tasks
Supervision and processing of discrepancies (events and deviations) as QA manager within BioPharma Drug Product Unit and Quality Control. Supervision and processing of OOX as QA manager. Performing process observations in the BioPharma Drug Product production units of sterile filling (isolators and RABS lines), visual inspection and packaging. Review and approval of change requests and documents within BioPharma Drug Product unit and Quality Control. Representing QA in audits and inspections. Ensuring regulatory compliance and adherence to international cGMP and internal regulations. Supporting the improvement of the internal quality management system and the definition of uniform standards. Contact person for all questions relating to quality in relation to production and QC processes during ongoing operations. Follow-up of quality-related tasks and decisions as well as independent decision-making for routine tasks. Proactive action and escalation when necessary. Staggered working hours and on-call duty, weekend work if necessary depending on production requirements.
Your profile
Master's degree with several years of professional experience or comparable professional qualification in the fields of pharmacy, biopharmacy, biology or chemistry. Advanced knowledge of biopharmaceutical manufacturing (sterile filling, visual control and packaging), especially with regard to compliance/quality relevant topics in process and quality control with many years of professional experience in GMP compliance and quality topics. Good knowledge of regulatory requirements. Experience in audits and inspections. Good negotiation and communication skills are required to achieve internal agreements as well as good team player. Good command of written and spoken English. Flexibility in work scheduling: staggered working hours and on-call duty, weekend work if necessary depending on production requirements.-
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