Job Description
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 with remote working options, we are recruiting a
Associate Quality Assurance (m/f/d)
Part-time (25-30 hours a week)
Fixed term - 1 year contract
We are looking for a motivated candidate to support our local GMP/GDP quality team, focussing on product related quality tasks (e.g. batch review, data collection, documentation) to ensure continuous compliance with regulatory and corporate requirements.
- Support quality review of batch documentation of products manufactured at external service provider: collecting and archiving of required records, preparing documents for review by the legal functions (Head of Production, Head of Quality Control, Qualified Person), starting of the signature process in the defined system
- Collaboration with Supply Chain team to prioritize batch release activities
- Take part in TrackWise Digital workflows for the assigned quality records product related (deviations, change controls, CAPAs and action items)
- Collect data for monthly score cards/reporting
- Support quality audits, self-inspections and Health Authority inspections
- Data collection for annual reviews (e.g. management reviews and Product Quality Reviews)
- Support the review of available Risk Assessments
- Degree in Pharmacy/Biology or scientific background
- Initial experience in Quality Assurance and Good Manufacturing Practices (GMP)
- Knowledge on biological products is plus, but not required
- Good interpersonal skills and sense of urgency to complete assignments on time
- Ability to analyse and work in detail
- Excellent record keeping skills in MS Word, Excel, PowerPoint; and database systems
- Effective communication skills in English (written and verbal). German is a plus.
- Open-minded, collaborative and willing to learn and grow in a fast paced and international environment
- Make a difference by joining our great team and ensure our products are available to patients
- A crisis-proof job in the pharmaceutical industry
- Targeted support and optimal opportunities for further training
- Above-average remuneration with 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 times