QA Ops Specialist

Gefunden in: Talent CH C2 - vor 2 Wochen

Visp, Schweiz Lonza Vollzeit

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

In we are looking for a Batch Record Reviewer to extend our team. You will report to the QA Operations Group Leader, work in close collaboration with different quality and operations functions in order to ensure cGMP-compliant manufacturing activities and documentation within QA

Key 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 shop floor QA oversight is a must ( 20%)

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.

Author, Review and approve GMP-relevant documents and SOPs

Responsible to present Drug Product QA Operations or support with other SMEs topics during the conduction of all customer audits, internal audits and regulatory inspections within DPS Visp / Biologics / Visp site.

Provide GXP-related trainings to Module D Operations personnel (eg. GMP, Good Documentation Practice,…)

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, recipes, manufacturing batch records, etc.

Review and approve executed batch records , prepare batch release for the responsible person (FvP), including recommendation on disposition status

Support continuous improvement programs to establish an effective Quality Management System for DPS Visp

Interact with customers for QA operations topics such as SOPs, change controls, deviations, complaints and others

Key requirements

Bachelor, Master degree or PhD in Biology, Chemistry, Biotechnology, Life Science or other related field

Previous experience in GMP regulated pharmaceutical / API industry is an advantage

Ability to identify non-compliance and gaps from quality standards

Structured, precise and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive

Full proficiency in English is a must, German or additional languages are a plus 

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Reference: R59820

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