You have experience in investigations, change control, validation and/or audits.
The QA Officer level 2 is responsible for providing advice, support and approval during 1. equipment installation, - qualification and –validation and 2. root cause investigation and corrective and preventive actions. In addition the QA officer level 2 reviews and approves standard production documentation and protocols and acts as a subject matter expert for the organization with regard to maintaining GMP compliance within the operational processes.
Your main tasks will be: timely review and approval of protocols, reports and deviations in accordance with guidelines and local procedures. Acts as a subject matter expert for GMP compliance during project and root cause investigations, change control procedures and improvement activities and approves final protocols and reports. Ensures correct administration and documentation of data in accordance with guidelines and local procedures. Acts as a mentor and coach for QA Officer level 1.
Our client is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products
Higher education degree HBO, University or equivalent. At least 5 years of relevant Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with demonstrated experience in investigations, change control, validation and/or audits. Extensive knowledge of Good Manufacturing Practice with the ability to interpret and apply in both routine and exceptional situations. Knowledge of pharmaceutical manufacturing processes. You have strong communication skills, both written and oral. Business proficient knowledge of Dutch and English language is mandatory. Further you have the ability to motivate others, including the ability to follow assignments through to completion and meet timelines. You are alos 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 give direction and set goals for individual employees, project members and working groups
Contactpersoon voor deze functie is Joost Storms, bereikbaar op telefoonnummer 023 55 78 529 of via e-mail: firstname.lastname@example.org Kenmerk: 7952.
XDES is specialist in recruitment van technisch personeel.
|Solliciteren Afdrukken Sluiten|