Biopharmaceutical Training and Compliance Specialist
vor 1 Woche
**Lonza: Where Science Meets Innovation**
We are a global leader in life sciences operating across five continents. At Lonza, we believe that our greatest scientific solution is talented people working together to devise ideas that help businesses improve lives.
In exchange for your expertise, we offer you the opportunity to own your career, with the freedom to make a meaningful difference in the world.
**Your Role:**
- Act as a change agent, supporting and promoting overall changes in the Drug Product department, with a particular focus on training activities.
- Liaise with operations teams to ensure training programs align with quality and business goals and support functional objectives.
- Support the development of training strategies and programs, as well as related materials to suit training at different levels.
- Provide training in classroom and shopfloor settings, including assessment of trainees' proficiencies and qualifications.
- Maintain relationships with external institutions and universities on expert training, vocational training, or re-training measures.
**Key Responsibilities:
- Complete manufacturing activities in the area of Drug Product according to cGMP guidelines, ensuring batch execution, evaluating test results, resolving issues, troubleshooting manufacturing equipment, and making recommendations for resolution.
- Support timely and high-quality production documentation (preparation and review of electronic batch records) specific to the assigned production area.
- Review production documentation and work on deviations, change requests, and implementation of CAPAs to ensure high-quality GMP standards.
- Write and/or adapt department-specific SOPs in the area of expertise.
**What We're Looking For:
- Bachelor's, Master's Degree, Ph.D., or equivalent experience, preferred area of study: Pharmaceutical Technology, Biotechnology, Chemistry, Pharmacy, or equivalent scientific degree.
- Experience in sterile drug product manufacturing is highly preferred.
- Proficient in English; knowledge of other languages is an asset, especially German.
- Familiarity with GMP requirements, quality procedures, and SOP execution.
- Structured, focused, and well-organized working attitude.
- Excellent communication skills and interaction with a variety of interfaces within the organization and on the shopfloor.
- Strong motivation and proactive approach; dedicated to finding solutions.
- Proven IT knowledge; knowledge in Trackwise, DMS, SAP, LSO, and Cornerstone is a plus.
**Benefits and Inclusion:**
- Relocation assistance is available for eligible candidates and their families, if needed.
- **Inclusion, Diversity & Belonging (IDB)**: We understand the value of our differences and the benefits they bring to our company, community, and culture.
**Salary Estimate:** $80,000 - $120,000 per year, based on location and experience.
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