FIXED-TERM CONTRACT (1,5 years)
- Site functional lead for Quality Control (QC) of marketed products. Lead and develop local site QC team Local line management responsibilities for QC Analytics (QCA) and Sample Management Departments (20 employees). Site Quality Control responsibilities including QC testing (release, stability, and raw material) and management of samples.
- Coordinate in vivo experiments with Laboratory Animal Facility and ensure compliant set-up in vivo QC testing (release and stability).
- Assure compliance with cGMP of all QC facilities, equipment, systems, and processes
- Keep up to date with current GMP guidelines, relevant pharmacopoeia and scientific knowledge in respect to QC testing requirement and methods.
- Technical oversight of tech transfer and all external QC testing activities.
- Assure that external and internal regulations for Environment, Health and Safety are fulfilled for all QC staff, facilities, systems and processes.
- Responsible for review/approval of QC test data, and QC-batch/sample result release, including trending, sample related deviations, Out of specification (OOS) and Out of control (OOC) investigation and timely escalation.
- Responsible for providing technical expertise support from QC to investigations and technical matters.
- Responsible for QCA test plans and internal QC resource planning to ensure timely delivery of QC results.
- Responsible for defining and maintaining the direct cost budget for the QC cost centers
- Review and approval of specifications, validation and qualification documents, as well as standard operation procedures of analytical methods and sample management
- Responsible for QC employees to have the necessary qualification, practical experience and competency.
- Responsible for premise and equipment to be maintained to suit its intended purpose
- Bachelor or Master Degree in Natural Sciences, with extensive work experience in the Life Science or Pharmaceutical Industry,
- Minimum of 5 years’ work experience within GxP regulated Life Science or Pharmaceutical Industry
- Experience of relevant GxP (GMP, GCP, GCLP) requirements for QC for the EU, US and Canadian markets in a commercial environment
- Used to work in an international environment with various cultures is desirable
- Strong management and leadership skills with ability to motivate and engage
- Proactive, solution-oriented and able to react in a fast changing environment
- Ability to manage and prioritize workload both for the organization as well as on a personal level
- Business fluent in English and German
- Open, appreciative company culture with innovative spirit and attractive assignments
- International surrounding with flat hierarchies
- Good team spirit in a strong and highly motivated team
- Wide range of benefits like flexitime, performance-related bonus, lunch vouchers, child care center (“Kindergarten”), company events
Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 65.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.