QA Specialist

Main Responsibilities :

• Act as QA representative in Project teams and represent QA in meetings
• Act as QA contact for specific topics and realize the interface for DRs and CRs
• Act as point of contact for Drug Product QA related questions, topics and complaints from customers related to the manufacturing operations
• Support and approve risk assessments or regulatory specific risk or gap assessments.
• Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.
• Represent Drug Product QA topics during regulatory inspections.
• Support continuous improvement programs to establish an effective Quality Management System.
• Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.
• Assess, review and approve quality records and release files / dossiers e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR / PQRs, in line with current local SOPs.

Qualifications and Experience :