Validation Engineer ( mfd)
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Job Location:
Skopje - North Macedonia
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Department:
Job Summary
- Independent planning implementation and organization of (re-)qualification and validation activities during projects including evaluation of test results and change/deviation
- - Monitoring of the necessary quality activities related to validation activities
- - Preparation of corresponding documentation in German/English in accordance with current guidelines - Support and if necessary organization of risk management activities within projects
- - Evaluation of changes regarding their impact on the qualified/validated status
- - Preparation of customer declarations
- - Creation and maintenance of test/sample sets - Support during audits (internal external suppliers)
- - Independent creation adaptation and expansion of related work instructions.
- - Ensuring continuous improvemen
Qualifications :
- Knowledge acquired during at least three years of (technical) university degree
- Five years of relevant professional experience in the areas of quality assurance qualification and/or validation.
- This position requires specialized knowledge in the areas of verification and validation.
- Knowledge of IT applications (e.g. Office programs MES QM system)
- Knowledge of problem-solving methods (e.g. KT)
- Good technical understanding in dealing with specifications
- User knowledge of project management methods
- Structured working method
- Proficient user in English Language
Additional Information :
All applicants are considered without any regard to color creed religion gender gender identity gender expression sexual orientation marital status veteran status disability genetic information citizenship status or membership or any other legally protected status. Preference is given to hiring people with disabilities.
Remote Work :
No
Employment Type :
Full-time
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Gerresheimer is the global partner for pharmaceutics, biotech, healthcare, and cosmetics with a very broad product range for pharmaceutical and cosmetic packaging solutions and drug delivery systems. The company is an innovative solution provider from concept to delivery of the end pr ... View more
