Das ist der Job
Provide subject matter expertise for CAPA and complaint management activities across ongoing improvement initiatives.
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).
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.
