Key activities & responsibilities

• Escalations and Significant Deviations: Act as the point of contact for quality-related escalations, providing clear and effective resolutions
• Product Transfers: Collaborate with cross-functional teams to ensure seamless product transfers across manufacturing sites
• Method Validations: Oversee and contribute to the validation of analytical methods to ensure reliability and accuracy
• Complaints Management (PQC): Investigate and resolve product-related complaints promptly and effectively
• Product Quality Reviews (PQRs): Conduct comprehensive reviews to ensure compliance with regulatory and internal quality standards
• Technical Documentation: Prepare, review, and maintain high-quality technical documents, reports, and presentations

Qualification

• Bachelor’s degree (minimum) in Pharmacy, Process Engineering, or Natural Sciences, advanced degree a plus
• Minimum of 5 years of relevant professional experience
• Solid experience in product quality, knowledge on solid oral dosage forms
• Background in pharmaceutical manufacturing or quality assurance
• Background method validation and product transfers is
• Strong understanding of pharmaceutical quality systems and regulatory requirements
• Knowledge of SAP or other ERP systems
• Experience in handling audits and regulatory inspections
• Proficient in technical writing and documentation
• A scientific mindset with problem-solving capabilities
• Fluent English, solid German skills
• Excellent communication and interpersonal skills
• Resilience and the ability to perform under pressure
• Collaborative mindset with the ability to work effectively in cross-functional teams
• Working independently, decision making

We offer

• Full-time position
• The chance to work for an international group
• Work place can be easily reached by public transport

 
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