Jobbeschreibung
Otsuka Novel Products GmbH (ONPG) is the global headquarter for a special pharmaceutical business within the Otsuka group. With an international network of 168 subsidiaries and 34,400 employees in 32 countries and regions across Europe, Asia-pacific, America and the Middle East, Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health.
Otsuka's Global Tuberculosis Project consists of teams and affiliates working on different aspects of the project, from medical research and clinical development, to commercialization, pharmacovigilance, regulatory issues, access strategies, strategic alliances and more.
For our office in Munich, we are recruiting a
Quality Assurance Manager (m/f/d) Part-time (25-32 hours a week)
In this role, you support the maintenance and improvement of the local GMP/GDP quality management system regarding commercial and investigational medicinal products to ensure continuous compliance with regulatory and corporate requirements. In addition, you manage and improve our local training system and documentation system and support the Head of Department as well as the Qualified Person.
- Coordinate overall SOP training assignments in the electronic training system (ComplianceWire) with the functional areas and global quality management and maintain the local training curricula
- Act as ONPG training representative also conducting quality management induction training for new employees
- Act as ONPG documentation manager managing the review of local/regional/global SOP in Veeva
- Participate in annual reviews (e.g. management reviews and product quality reviews)
- Take part in the TrackWise Digital workflows for the assigned quality records (deviations, complaints, change controls, CAPAs and action items)
- Participate in risk assessments
- Support self-inspections and health authority inspections
- Support quality review of batch documentation and document preparation for product releases by the Qualified Person, including archiving
- Initiate and perform monthly quality system reviews and prepare monthly score cards
- 3 years of proven experience in Quality Assurance and Good Manufacturing Practices (GMP)
- Knowledge/experience in relevant regulations and guidance documents (AMG, AMWHV, EU-GMP/GDP, EU FMD)
- Very good communication skills in English (written and oral). German is a plus.
- Open minded, details/effort oriented, good problem solving and resolution skills
- Hands-on approach to GxP Computer system
- Well versed with MS Office, Excel and PowerPoint
- Make a difference by joining our great team and global fight against Tuberculosis
- A crisis-proof job in the pharmaceutical industry
- Targeted support and optimal opportunities for further training
- Above-average remuneration with company pension scheme, attractive bonus model, home office allowance, holiday allowance and others
- Attractive employee benefits incl. wellbeing benefits, employee assistance program, private travel health insurance for abroad travels
- Modern office centrally located in Munich near Hackerbrücke
- Partial home office and flexible working hours