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Manufacturing Compliance Specialist
vor 2 Monaten
Job Summary:
We are seeking a skilled Manufacturing Compliance Engineer to support our Drug Substance Manufacturing operations.
Key Responsibilities:
- Provide technical support and solutions in USP, DSP, and Solution Preparation areas.
- Oversee equipment installation, maintenance, and calibration, ensuring 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.
Qualifications:
- 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.
- Willingness to travel occasionally and availability for remote on-call duties.
What We Offer:
- A multifaceted job in a dynamic and international environment.
- Competitive remuneration and comprehensive benefits package.
- Outstanding career and development prospects.
- A culture that lives integrity, intensity, involvement, and innovation.
- Well-founded induction and task-specific training.
About Thermo Fisher Scientific:
We are committed to equal opportunity and cultural minority support and do not discriminate based on ethnic origin, color, religion, gender, sexual orientation, gender identity, national origin, disability, or legally protected status.
