QA Associate (Rotkreuz, Part-time 0.8 FTE, English, German)
D-ploy is an IT and Engineering Solutions company with operations throughout the EMEA region including Switzerland, Germany, Czech Republic, Austria, UK, as well as the USA.
We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT community, we optimize our customer‘s IT productivity and contribute to the organization’s success and value.
We are interested in talking to engaging, flexible, and solution-oriented individuals who are looking to become a part of a dynamically growing and international organization. We are focused on creating value where IT counts, join us!
Tasks and Responsibilities
- Ensure compliance with local legislation and corporate regulations
- Maintain and develop quality systems within the local quality organization
- Drive and support processes related to marketed products, including batch release and complaints handling
- Act as the business partner for various functions at the interface between manufacturing and the market
- Follow GxP and corporate guidelines in day-to-day work
- Act as Subject Matter Expert (SME) in the area of responsibility
- Take over process ownership as assigned, ensuring proper functioning, monitoring, and continuous development of processes within corporate regulations and local legal requirements
- Handle and investigate deviations, including their Corrective and Preventive Actions (CAPAs)
- Maintain and update the quality management system within the area of responsibility
- Perform administrative and supportive tasks as required
- Support readiness for all GxP regulatory inspections & audits, as well as self-inspections according to plan
- Meet Key Quality Indicators (KQI) in the area of responsibility; assess, report, and proactively monitor KQIs, maintain good oversight, and ensure gaps are appropriately addressed
- Drive and execute continuous improvement in the area of responsibility
- Minimum apprenticeship in Natural Science (e.g. laboratory technician, aide in Pharmacy, bachelor’s degree in natural sciences) or comparable education/scientific background with experience in the GxP area
- Fluency in German and English (oral and written); French is an advantage
- 3-5 years of professional experience in the pharmaceutical industry, analytics, quality assurance, production, distribution, or pharmacy
- Strong interpersonal, communication, negotiation, and problem-solving skills
- Skills in project management, including a simplification mindset, strategic thinking, and the ability to implement changes
- All candidates must provide a Criminal record not older than 3 months
- Broad range of activities, tasks, and projects
- Flexible working conditions
- Vouchers (B-day voucher, wedding, and new born surprise)
- Fishing for Friends program – our referral program
- Refreshments in the D-ploy office
- Further development and professional advancement
- Friendly and international working environment
- Company-sponsored events
- Competitive salary and various benefits
Is IT in your DNA?
Über die Firma
