The QA officer is a position within the center of excellence Quality Operations (CoE QO) of MSD. The CoE QO is comprised of several departments designed to oversee manufacturing activities in accordance with current Good Manufacturing Practices (cGMP) and is responsible for ensuring compliance of manufacturing, receipt, storage, testing, processing, packaging, release, holding, labeling and distribution activities during the life cycle of products. The QA officer is positioned within the QA-Integrated Process Team (IPT) department.
The QA officer is responsible for providing advice, support and approval during equipment installation, qualification and validation. Also responsible for providing advice, support and approval during root cause investigation and corrective and preventive actions. In addition the QA officer 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.
The open position will be placed within QA-IPT, which is responsible for the quality oversight within IPT.
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 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.
Advocates safety culture within the organization.
Indicates opportunities for improvement and takes part in or leads projects in order to implement changes.
Acts as a mentor and coach for junior QA officer.
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.
Reviews and approves deviation investigations.
Participates in internal and external audits and projects as required.
Supports MSD Animal Health training initiatives (i.e. development of training modules, actual training of individuals).
Desired skills & experience
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 biological manufacturing processes.
Strong communication skills, both written and oral.
Business proficient knowledge of Dutch and English language is mandatory.
Self-motivated and the ability to motivate others.
Strong organizational skills and ability to manage multi tasks at one time, including the ability to follow assignments through to completion and meet timelines (commitment to task, attention to detail).
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.