Senior QA Specialist, DPS (Drug Product Services) 80-100% (f/m/d)

Responsibilities

• 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

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, preferably in Drug Product
• Experience working in a QA department is strongly required
• Fluent English language skills are required, German language is an advantage
• About Lonza
• Ready to shape the future of life sciences?

Additional Information

Location: the actual location of this job is in Visp, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. 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 get: An agile career and dynamic working culture An inclusive and ethical workplace Compensation programs that recognize high performance A variety of benefits dependant on role and location The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits .

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