Beschreibung

In this role, you will ensure the quality and compliance of incoming goods through meticulous testing and data review. You will also lead technical initiatives and mentor team members to enhance laboratory capabilities.

Anforderungen

• •Master’s degree or Bachelor in Analytical Chemistry, Chemistry, or Biology with extensive practical experience in GMP related field
• •Minimum of 5-10 years of regulated industry experience in QC with demonstrated knowledge of related quality systems and regulatory requirements
• •Hands-on experience in Chemical testing and relevant method validation/transfer per ICH guideline, including HPLC and UV-Vis
• •Experience in working with Empower, LIMS and LES
• •Written and oral skills in German and English
• •Participation in Regulatory inspections as a SME such as EMA, FDA, etc.

Aufgaben

• •Ensure timely completion of work to support batch release
• •Adhere to EHS requirements and laboratory safety procedures
• •Maintain cleanliness and contamination control per cGMPs
• •Execute activities in compliance with SOPs and regulatory guidelines
• •Record data according to data integrity standards
• •Perform data review to ensure accuracy and compliance
• •Identify and escalate atypical results and potential deviations
• •Participate in root cause analysis for laboratory investigations
• •Communicate opportunities for continuous improvement
• •Participate in cross-functional teams as required
• •Maintain training competencies and participate in mentorship
• •Support audit and inspection readiness activities
• •Perform comprehensive data reviews and prepare certification documents
• •Participate in method transfers and validations
• •Provide technical direction for the QC laboratory
• •Lead resolution of complex QC technical challenges
• •Collaborate across functions to integrate QC considerations
• •Serve as a subject matter expert during regulatory inspections
• •Mentor QC staff on advanced concepts and problem-solving techniques
• •Sample incoming goods according to the sampling plan
• •Handle samples to prevent contamination
• •Label and document sample collection as per local procedures
• •Transport samples to the designated area in a timely manner
• •Communicate with Warehouse and QA to ensure proper sample collection
• •Perform testing on incoming goods per established laboratory procedures
• •Conduct routine checks and cleaning on equipment
• •Report equipment malfunctions and coordinate maintenance

Tools & Technologien

Benefits