Senior QA (Quality Assurance) Officer
Location: The Netherlands
Client: Our client is a biopharmaceutical manufacturing company specialising in the production of bulk Active Pharmaceutical Ingredients (API) / Bulk Drug Substances.
The Quality Affairs/Assurance Officers serve to ensure that cGMP manufacturing activities that require Quality engagement are completed in accordance with typical cGMP requirements, adhere to the approved SOPs that govern the activity of interest, are consistent with emerging/existing corporate & regulatory guidelines as necessary and are continuously improved through leveraging the Quality Systems architecture of the organization.
• Quality on the floor: real time direct engagement of Quality professionals with manufacturing shop floor operations including cGMP guidance, document review and approval, deviation advice and advice regarding documentation quality practices.
• Significant shift work may be required.
• Knowledge of and direct experience with validation practices, principles, documentation and outcomes.
• Understanding of Quality Assurance practices and principles across the full spectrum of site manufacturing services (e.g. development, clinical, process performance qualification, and commercial manufacturing)
• Experience with the practical application of various risk assessment tools (i.e. failure mode effect analysis, fishbone diagrams, and hazard and operability studies) and the ability to directly develop, participate and advise others on the appropriate and efficient application of these processes.
• Understanding of the connection between floor documentation and the batch disposition process.
• Ability to advise, facilitate, and support all phases of manufacturing batch documentation development including, but not limited to the initiation, authoring, approval and mastering.
• Experience with the responsibilities associated with Quality review and approval of cGMP documentation.
• Alignment of SOPs, documentation practices, laboratory testing, and efficient documentation flows in the Quality release of raw materials, buffers/media and area/equipment.
• Use, scope, development and orchestration of incident investigations toward the goals of both adequately understanding root cause and avoiding repeated incidence.
• Knowledge of and practical experience in the application of cGMP change control.
• Knowledge and experience with the application and maturation of Quality/Operations Systems toward the goal of establishing a stable and efficient architecture for systemic continuous improvement.
• Ability to work with complex and comprehensive electronic databases (e.g. Trackwise) to document events related to product quality.
• Experience with regulatory inspection practices from readiness exercises through direct agency engagements.
• Ability to work in a highly dynamic, frequently changing environment with a wide variety of people and perspectives.
• Willingness to operate in a variety of modes as it pertains to risk adjusted Quality oversight models driven by the mode of manufacturing being employed.
• Understanding of the practical application of the principles and practices necessary to be successful in a highly regulated environment.
• Strong technical understanding of all phases of mid-scale, disposable modality, mammalian manufacturing technology and practices.
• Ability to effectively communicate in multiple modalities.
• Understanding of the philosophies and methodologies of LEAN manufacturing including visual factory approaches, waste identification and removal, kaizen applications, gemba walks, and process flow development among others.
• Knowledge of and experience with area and system auditing practices
Skills & Experience Required:
• HBO level in a relevant discipline (Biochemistry, Microbiology, Biotechnology, Pharmacology) or equivalent.
• Minimum of 3 years relevant experience in a (bio) pharmaceutical company.
• Knowledge of pharmaceutical cGMP systems and international cGMP regulations and guidelines.
• Experience with project management.
If you are interested in proceeding with this role, please send through your up-to-date CV in English to firstname.lastname@example.org and we can arrange a confidential discussion to go through your experience in more detail.
Notwithstanding any guidelines given to years of experience sought, we will consider candidates from outside this range if they can demonstrate the necessary competencies.
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