Manufacturing Compliance Specialist
vor 3 Wochen
This role combines technical expertise with strong communication skills to ensure successful collaboration with various departments and external partners. As a key member of Thermo Fisher Scientific's team, you will be responsible for delivering high-quality results, driving process improvements, and ensuring compliance with industry standards.
Responsibilities:
- Provide technical support and expertise in Drug Substance Manufacturing areas, including USP, DSP, and Solution Preparation.
- Supervise equipment installation, maintenance, and calibration to ensure top performance and alignment to industry standards.
- Ensure quality, safety, and compliance by reviewing exceptions, supporting batch record reviews, and leading deviation investigations & CAPAs.
- Drive continuous quality and process improvements using Practical Process Improvement (PPI) methodologies.
- Collaborate with various departments and represent DS Manufacturing in external interactions.
- Take personal accountability for presence, performance, and efficiency.
- Think and act with a customer-centric approach.
Requirements:
- Bachelor/Master/PhD in Chemistry, Biochemistry, Biotechnology, Biology, or Food Science.
- Proficiency in English; German is a plus.
- Minimum of 5 years in pharmaceutical operations within a GMP environment.
- Strong experience in biotech processes, sterile processes, and production equipment handling.
- Willingsness to travel occasionally and availability for remote on-call duties.
As a key member of our team, you will have the opportunity to work in a dynamic and international environment, receive competitive remuneration and comprehensive benefits package, and enjoy outstanding career and development prospects.
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