Senior QA Specialist, DPS (Drug Product Services) 80-100% (F/M/D) at Lonza | Torre

Senior QA Specialist, DPS (Drug Product Services) 80-100% (F/M/D)

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Part-time

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3930 Visp, Switzerland
Shared by
Julien PETIT
3 months ago

Responsibilities


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 DoRepresent 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 processesAct as point of contact for Drug Product QA related questions and issues related to the manufacturing operationsEnsure manufacturing shop floor QA oversightAssess, review and approve quality records e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs in line with current local SOPsReview 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 siteProvide 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 VispWhat We Are Looking ForUniversity degree or equivalent in Chemistry / Biology / Biotechnology or a related fieldLong-term experience working in the GMP environment of the pharmaceutical industry, preferably in Drug ProductExperience working in a QA department is strongly requiredFluent English language skills are required, German language is an advantageAbout LonzaAt Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.What You Will GetAn agile career and dynamic working cultureAn inclusive and ethical workplaceCompensation programs that recognize high performanceA variety of benefits dependant on role and locationThe full list of our global benefits can be also found on https://www.lonza.com/careers/benefits .Reference: R77140