Quality Assurance Manager (m/w/d) Computersystemvalidierung (CSV)

Company : Midas Pharma Gmbh

Job Type : Full Time

Ingelheim

Job Description - Quality Assurance Manager (m/w/d) Computersystemvalidierung (CSV)

Planning, coordinating and implementing the validation of computerised systems in accordance with applicable regulations
Ensuring compliance with legal requirements during all phases of the validation of computerised systems
Management of all documents arising from validation projects
Implementation of risk management in the computerised validation environment (CSV)
Preparation of final validation reports
Ensuring data and system security
First point of contact for all questions relating to validation processes
Planning, support and monitoring of validation, qualification and calibration measures
Coordination and administration of deviation management
Preparation and review of GMP-related documents

Degree in computer science or natural sciences and several years of professional experience in quality management in the pharmaceutical industry
Sound knowledge of the validation of computerised systems in the pharmaceutical industry
You are familiar with the current GMP requirements and guidelines for the validation of computerised systems (GAMP5)
High organisational skills, result-oriented way of working and quick adaptability
Good communication skills, enjoy interdisciplinary work
Very good knowledge of German and English

Midas Pharma is a well-established and renowned family business that offers you a personal and appreciative working atmosphere in addition to the security of over 30 years of business
Our workplaces are not open-plan offices, but personal offices where you can also retreat from time to time, equipped with the latest technology and ergonomic office furniture
Our organization enables you to make quick decisions - a key factor of our success
Due to our flat hierarchies, there is a very close interaction at Midas - personal and professional - it is not uncommon for management to be involved in interdisciplinary projects
We are looking for you as a personality and want you to contribute authentically - in turn, we encourage this by giving you great freedom for creativity and independence
At Midas, all paths to personal and professional development are open to you - various support programs as well as assignments abroad are just a few possibilities

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Quality Assurance Manager (m/w/d) Computersystemvalidierung (CSV)

Job Description - Quality Assurance Manager (m/w/d) Computersystemvalidierung (CSV)

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