Senior QA Specialist, DPS (Drug Product Services)

Senior QA Specialist, DPS (Drug Product Services)

Lonza

Visp, Switzerland

You will 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.

What you will do:

• 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;
• Act as point of contact for Drug Product QA related questions and issues related to the manufacturing operations;
• Ensure manufacturing shop floor QA oversight;
• Assess, review and approve quality records e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs in line with current local SOPs;
• Review and approve GMP-relevant documents (SOPs, protocols, risk assessments, manufacturing process descriptions, equipment recipes);
• Review and approve executed manufacturing batch records or other executed GMP documents (logbooks, forms, protocols);
• Responsible to present Drug Product QA topics during the conduction of internal audits as well as customer audits and regulatory inspections within DPS Visp/Biologics/Visp site;
• Provide GXP-related trainings to Module D Operations personnel (eg. GMP, Good Documentation Practice, Good Aseptic Behavior);
• Support continuous improvement programs to establish an effective Quality Management System for DPS Visp.

What we are looking for:

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