QA Project Manager - Drug Product

QA Project Manager - Drug Product

Lonza

Visp, Switzerland

What you will do:

• Establish Quality Agreements (QAA) in close collaboration with Drug Product Services DPS in Basel/Stein and LONZA Drug Substance (DS) sites (e.g. Slough/Visp).
• Act as QA representative in Project teams and represent QA in customer meetings during Technical Transfer.
• Act as QA contact for specific projects and realize the interface for DRs and CRs with the customer (routine follow-up’s).
• Act as point of contact for Drug Product QA related questions, topics and complaints from customers related to the manufacturing operations.
• Organize customer audits together with the Visp Compliance team and DPS Basel functions.
• Support and approve project/product specific 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.
• Work closely with QC-Project Leader (QC-PL) and MSAT for New-Product-Introductions (NPI).
• Support general organization of inspections (front/back office).
• 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.

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.
• Experience working in a QA department would be an advantage.
• Business fluent English is required, German language skills are an advantage.