QA Specialist

QA Specialist

Job description:

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 for Visp DPS.
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.

Requirements:

University degree or equivalent in Chemistry / Biology / Biotechnology or a related field
Long-term experience working in the GMP environment of the pharmaceutical industry
Experience working in a QA department Drug Product
English language skills are required, German language is an advantage