Website Gerresheimer
Gerresheimer
Company : Gerresheimer
Job Description
Independent planning, coordination and implementation of necessary qualification and validation activities related to all production and support processes including corresponding documentation
Validation activities during the projects including evaluation of test results and change/deviation management (e.g. for Production equipment, systems, software, peripherals, buildings and facilities etc.)
Monitoring of the required quality activities around the Validation activities (e.g. ordering test equipment, material qualification, supplier matters)
Creation of corresponding documentation according to the work instructions
Support and, if necessary, organization of risk management activities within the projects
Changes evaluation in terms of their impact on the qualified/validated state
Carry out requalification activities
Creation of customer declarations etc. (possibly in cooperation with others positions e.g. Regulatory Affairs)
Create and maintain test/sample sets
Support for internal audits, customer audits and if needed supplier audit
Contribution to new procedures, procedure updates and improvements (process descriptions work instructions)