XDES is specialist in recruitment van technisch personeel.
The QA Officer is responsible for providing advice, support and approval during:
- root cause investigation and corrective and preventive actions.
- change control of procedures and processes.
In addition the QA Officer reviews and approves standard production documentation and protocols and can act as a subject matter expert for the organization with regard to maintaining GMP compliance within the operational processes.
- Timely review and approval of protocols, reports and deviations in accordance with guidelines and local procedures.
- Ensures correct administration and documentation of data in accordance with guidelines and local procedures.
- Advocates safety culture within the organization.
- Indicates opportunities for improvement and takes part in projects in order to implement changes.
- Reviews and approves changes and associated documentation.
- Monitors activities concerning compliance and ensures validated status of GMP processes and systems.
- Ensures that Quality policies, procedures and programs are properly implemented in daily GxP operations and remain up to date.
Higher education degree in a relevent arena. HBO or equivalent. At least 3 years of relevant Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with demonstrated experience in investigations, change control, validation and audits. Knowledge of Good Manufacturing Practice with the ability to interpret and apply in both routine and non-routine cases.
You have strong communication skills, both written and oral. Business proficient knowledge of Dutch and English language. Further you have the ability to motivate others, including the ability to follow assignments through to completion and meet timelines. You are also able to make decisions in a highly complex environment that balance business needs, quality and compliance risk and other constrains. Finally, you have the ability to provide direction and support goalsetting for individual staff members and work groups.
Salary and Benefits
Contactpersoon voor deze functie is Joost Storms, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: firstname.lastname@example.orgHelp Kenmerk: 8193.