We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Quality Assurance Specialist
- Surveillance and maintenance of the Quality Management-System regarding EN ISO9001 in cooperation with the QMR.
- Surveillance of compliance with PLx training standards and documentations
- Oversight, maintenance and administration of PLx Training System (Q-MET)
- Organising and performing trainings
- Improvement of Q-MET by identification of weak points and development of concepts for the elimination of the identified weak points.
- Continuous check and coordination of regular review and updates of procedural documents
- Administrative support concerning quality management related projects and activities
- Support regarding CAPA handling
- Support regarding Vendor qualification
- Support system validation Q-MET
- Support for creation of validation documents (e.g. Master Validation Plan, System Validation Plan, Final Validation Report)
- Preparation of guidance documentation
- Reporting to Senior Director QA on status of PLx Quality Management System
- Autonomous, concentrated and high-quality work
- Ability to work in a team
- Sense of responsibility
- Good command of English, German language skills advantageous (optional)
- Familiarity with actual principles of Quality Management and Quality Assurance
- Detailed knowledge of the related SOPs
- Ability to organise operational procedures and to take over project leadership
- Excellent verbal or written communication skills
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.