Join the Quality Control department as a QC Officer Environmental Monitoring/Utility Monitoring, where you'll ensure compliance with GMP regulations and SOPs. As a subject matter expert, you'll provide guidance and support to maintain high standards of quality and regulatory compliance. Collaborate with cross-functional teams to drive continuous improvement, conduct audits, and manage investigations. Enjoy a dynamic role with opportunities for professional growth and development. Find out why this job might be the perfect match for your skills.

Over het bedrijf

Prothya Biosolutions

Directe werkgever

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As a Quality Control (QC) Officer Environmental Monitoring (EM)/Utility Monitoring (UM), you will play a pivotal role within the Quality Control department, responsible for ensuring compliance with Good Manufacturing Practice (GMP) regulations, Standard Operating Procedures (SOPs) and quality management system requirements. This position serves as a subject matter expert on quality control EM/UM practices, providing guidance, support and oversight to ensure the integrity and reliability of analytical testing and data generation. As a QC Officer EM/UM you will collaborate with cross-functional teams to drive continuous improvement initiatives and uphold the highest standards of quality and regulatory compliance.

Your responsibilities:

Investigations into laboratory deviations, non-conformances, out-of-specification (OOS) results and customer complaints, driving root cause analyses and implementing corrective and preventive actions (CAPAs) as needed.
Conduct routine audits and inspections of laboratory operations, documentation and facilities to assess compliance with GMP regulations and company quality standards.
Provide guidance to QC Analysts, Technicians and other laboratory personnel on quality control practices and regulatory requirements.
Collaborate with Quality Assurance, Manufacturing and other departments to support product release and investigations.
Participate in cross-functional teams and project groups to support product release and investigations.
Act as SME for all QC OPS quality related subjects

Your profile:

Education: Bachelor’s degree in Chemistry, Pharmaceutical Sciences, or a related field.
Experience: Minimum of 3 years in a QC position involved in EM/UM and working in a cleanroom environment.
Strong knowledge of microbiology.
Strong understanding of GMP and regulatory requirements.
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.
Fluency in Dutch and English

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.

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