Darum lohnt es sich
Solid Dosage Manufacturing Consultant
6 months, full time B2B contract
Key Responsibilities
• Lead investigations into selected GMP deviations, identifying root causes and supporting the development and implementation of effective corrective and preventive actions (CAPAs).
• Provide subject matter expertise for CAPA and complaint management activities across ongoing improvement initiatives.
• Draft, review, and update SOPs, work instructions, and other GMP documentation to ensure compliance and operational effectiveness.
• Perform quality risk assessments (e.g.
FMEA) and recommend appropriate mitigation strategies based on identified risks.
• Develop and deliver GMP training sessions, sharing best practices and ensuring compliance with current regulatory expectations.
• Review manufacturing records, batch documentation, and quality-related documentation for GMP compliance and accuracy.
• Support department leadership on defined quality improvement and GMP compliance projects, acting as a technical advisor.
• Provide specialist guidance on GMP requirements and best practices within solid oral dosage manufacturing.
Required Experience
• Degree in Life Sciences, Pharmacy, Chemistry, Engineering, or another relevant scientific discipline (or equivalent industry experience).
• At least five years of experience within a GMP-regulated pharmaceutical manufacturing environment.
• Minimum three years of hands-on experience supporting solid dosage (oral solid dose) manufacturing operations.
• Strong knowledge of EU GMP requirements, deviation investigations, CAPA processes, and quality management systems.
• Demonstrated ability to work independently with a structured, analytical, and solution-focused approach.
