Senior Quality Assurance Officer Job Description
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About the Role:
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The Senior Quality Assurance Officer will be responsible for managing the project portfolio of new and existing products from early development to routine commercial production, ensuring compliance with legal, market, and customer requirements.
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Responsibilities:
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* Ensure that production processes are consistent with registered and customer requirements, including validation plans and evaluation of validation reports.
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* Collaborate with R&D, Production, QC, IPC, and other departments to deliver in-depth investigations into deviations and changes in production processes.
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* Analyze critical data to decide on the final release of API, intermediates, or final products, ensuring compliance with cGMP, customer, and legal standards.
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* Develop a deep understanding of stakeholders' needs and concerns, fostering long-term relationships with internal and external partners.
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* Lead external project-related audits, accompanying customers and authorities to ensure a fair view of process-related quality documentation.
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Requirements:
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* Masters degree in Science or equivalent experience with good knowledge of organic and analytical chemistry, and pharma regulations.
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* First professional experience in a quality or production-related environment, preferably with GMP experience.
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* Able to oversee different processes with a helicopter view, possessing a critical and analytical mindset.
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* Excellent communication skills, able to express arguments clearly and build strong relationships internally and externally.
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* Fluency in Dutch and English (spoken and written), with a structured work approach and ability to organize work efficiently.
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* Ability to work independently and as part of a team, with an operational excellence mindset.
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* Good working knowledge of MS Office and Outlook, with experience in SAP and Sharepoint a plus.
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What We Offer:
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* A challenging position at an international company with a leading position in the pharmaceutical sector.
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* A dynamic and collegial working environment with a focus on support, training, and personal development.
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* An attractive salary package with extensive fringe benefits.
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* A commitment to a safe, inclusive work environment and diversity.
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