MSD Senior Quality Specialist m/f/d 

Austria, Lower Austria 

274816729

Job Description

The Senior Quality Specialist provides Quality support and oversight according to Austrian Drug Law (AMG), European GMP, EU 2019/6 and USDA at Krems Site in Austria.

Main tasks

• Responsibility for one's own safety and that of the immediate environment

• Participate and provide QA leadership for investigations and risk assessments related to deviations, complaints and changes, ensuring appropriate actions are implemented timely

• Assist in the creation and maintenance of QA policies, SOP’s and reports in line with site requirements

• Review and approve relevant SOPs, qualification and validation protocols and reports, manufacturing instructions, GMP documents included but not limited to warehouse, manufacturing, QC, maintenance, engineering

• Provide guidance on GMP and ensure quality and compliance with the relevant GMP regulations, such as EU GMP guidelines and pharmacopoeias

• Participate in and support risk management activities in line with relevant guidance and best industry practice

• Participate and support official inspections and self-inspections

• Participate in projects for quality improvement, transfer and optimization of products and methods

• Contribute to the implementation of quality and compliance excellence for continuous improvement and increase in efficiency throughout quality and, where necessary, support initiatives at the site and company levels

• Work collaboratively to foster strong relationships with management and colleagues to drive a safe and compliant culture

Skills

• Minimum a bachelor’s degree in microbiology preferred, (Bio)chemistry, Biology, or scientific field

• Minimum 10 years of experience in a Pharmaceutical GMP environment

• Good knowledge of EU GMP regulations as well as (V)ICH guidelines

• Knowledge of PDA, ISPE guidance

• Experience in aseptic processes

• Eligible to be a Qualified Person preferred

• Fluent in German and English

We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position isEUR 59.200and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.

Current Contingent Workers apply

Not Indicated

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.