Senior Quality Specialist

Job Description

About the Role

Title: Senior Quality Specialist in 50% (m/w/x) – QA Filling

Location:  DE, Marburg

Part time

job requisition id: R-250595

Job Description:

Part-time 18.75 hours / limited 18 months*

The task:

You are responsibleforquality management in the area of Filling & Visual Inspection under the general guidance of the supervisor and ensuring quality oversight in accordance with SOPs and regulatory requirements

They supported in all questions of quality assurance in ongoing production activities, projects and shutdowns to ensure GMP compliance, including GMP inspections

Creating change requests and processing, coordinating or evaluating and approving deviations in the area of responsibility are also part of your tasks

You evaluate, coordinate and implement complex CAPAs and take on the preparation, review and approval of complex risk analyses

Your tasks include support, preparation and accompaniment of national and international authority and customer inspections, as well as the implementation of self-inspections outside your own area of responsibility in accordance with QAS audit management specifications

Conducting GEMBAs on the shop floor

Evaluation and implementation of measures within the framework of continuous improvement

Preparation of parts of the APQR, review and evaluation of trend analyses, change requests and deviations within the APQR and final evaluation of the APQR

You check and evaluate the GMP and batch documents as well as deviations within the framework of pharmaceutical-technical complaints (PTR)

Leading local and global project teams to improve processes, systems and standardize workflows and processes are also within your area of responsibility

Your skills and experience:

usually completed degree ‘Bachelor of Science’

professional experience of 4-5 years

Knowledge and experience in dealing with risk and quality management tools, methods and systems and in the relevant legal texts / guidelines

Knowledge of aseptic/sterile filling of biopharmaceuticals

Good knowledge of deviation management

Experience in the operational application of quality assurance systems

Experience in pharmaceutical manufacturing and testing processes; experience with authorities

Knowledge and experience in using project management tools

Fluent in spoken and written     English

Our discounts and additional services

bike leasing with discounted conditions

Hybrid working model (close consultation, usually 2 days/week remote)

Use of a long-term account e.g. for a sabbatical

The KiTa ‘Froschkönig’ for employees’ children offers up to 14 places close to the site

sports groups and mindfulness offerings

Professional help with individual challenges and problems in everyday life – even outside of work

Further information can be found below under the heading ‘What we offer’

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more abouthow we careat CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more aboutCSL Behring.

We want CSL to reflect the world around us

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more aboutDiversity & Inclusionat CSL.