QC Officer - Quality Control Operations

As a Quality Control (QC) Officer in our Quality Control Operations, you'll play a pivotal role in maintaining the highest standards of product quality and compliance. Your expertise in Good Manufacturing Practice (GMP) and quality management will guide our teams, ensuring that every product meets our rigorous standards. You'll be actively involved in identifying and resolving quality issues, performing inspections, and driving continuous improvement initiatives. If you're detail-oriented and enjoy collaborative problem-solving in a complex organisation. As such, this role offers both challenge and fulfilment.

About the Role

As a QC Officer in our Quality Control Operations, you'll play a pivotal role in maintaining the highest standards of product quality and compliance. You will act as an SME in performing investigations, constantly looking for information: who, what, where, why and defining solutions to prevent from happening again. This role involves collaboration with different people within the organization and is therefore important to be a good listener, helper, thinker and sometimes persuasive to get colleagues on board with the necessary changes. It is also important to learn to deal with setbacks, as there can be times when decisions are made that you do not fully support. If you're detail-oriented and enjoy collaborative problem-solving in a complex organisation. As such, this role offers both challenge and fulfilment.

Responsibilities:

• Demonstrates independent understanding and application of GMP fundamentals, including but not limited to: Good manufacturing practices, good documentation practice and data integrity.
• Perform investigations on non-conformances, deviations, and out-of-specification (OOS) results. Is acknowledgeable of root cause analysis tools.
• Conduct routine audits to ensure compliance with GMP and quality standards.
• Support and guide laboratory personnel in quality control practices and regulatory requirements.
• Collaborate with cross-functional teams to facilitate product release and resolve quality issues.
• Assist in identifying and implementing improvements Requirements

Your profile:

• Bachelor or Master degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
• >5 years work experience within analytical chemistry in a QC environment in the pharmaceutical or biotech industry.
• Strong understanding of GMP and regulatory requirements.
• Experience in deviation management, on how to perform investigations, root cause analysis and define corrective and preventive actions.
• Ability to lead investigations and manage CAPA processes.
• Experience with measuring-equipment, qualification, and maintenance.
• Analytical thinking and problem-solving abilities.
• Excellent communication and interpersonal skills for cross-functional collaboration.
• Articulate written and oral communication, able to deliver effectively a message
• Proficiency in documentation practices and attention to detail.
• Ability to work under stress, while being able to prioritize tasks.
• A true team player, you want your colleagues to be happy and successful too
• Strong grasp of English, both verbal and written. Dutch advantageous.
• Ability to work on-site.

What We Offer:

• Full-time employment (40h) with flexible working hours in consultation.
• 8.33% end-of-year bonus and 8.33% holiday allowance.
• A personal training budget of €2,100 every three years to foster professional growth and development.
• Contribution to travel expenses from the first kilometer.
• Excellent accessibility by public transport and private parking available.
• A pension plan with Zorg & Welzijn, providing security for your future.
• A dynamic, safe, and challenging working environment with ample opportunities to grow, innovate, and learn, all while making a meaningful impact on the health of millions.

Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.