QA Production Specialist
Bekijk en reageer bij SIRE Life Sciences B.V. (externe link)
QA Production Specialist voor een internationale farmaceutische organisatie in Haarlem, Noord-Holland, ter ondersteuning van farmaceutische productie en packaging.
- Locatie
- Haarlem
- Werkvorm
- op locatie
- Contractvorm
- detachering
- Startdatum
- Eerste waarneming
- Opdrachtgever
- International pharmaceutical organization
Eisen
- Experience reviewing SOPs, BMRs, validation protocols and GMP documentation
- Knowledge of (aseptic) pharmaceutical processes and production control systems
- Strong knowledge of GMP and Quality Assurance systems
- Strong quality-oriented, collaborative and results-driven mindset
- Master's degree or equivalent academic working level, preferably in Pharmacy, Chemical Engineering or a related field
- Ability to work effectively in a dynamic and demanding production environment
- Experience with deviations, root cause investigations and CAPAs
- Strong analytical, advisory, communication and reporting skills
- Experience within the pharmaceutical industry and production environment
- Excellent command of spoken and written English
Omschrijving
Our client is an international pharmaceutical organization focused on the development and production of high-quality medicines. Within a regulated production environment, the organization places strong emphasis on GMP compliance, quality assurance, continuous improvement and patient safety. As a QA Production Specialist, you will provide quality assurance support to pharmaceutical production, covering both bulk manufacturing and packaging activities. You will support production teams with deviations and quality issues, lead or contribute to root cause investigations and CAPAs, and assess the impact of deviations on production activities. You will also review GMP documentation, support audits and compliance investigations, contribute to improvement projects and provide quality-related training and knowledge transfer within the organization. Key responsibilities include providing QA support to pharmaceutical production, including bulk manufacturing and packaging; supporting production teams with deviations, quality issues and compliance questions; assessing deviations and advising whether production activities should be halted when required; investigating and documenting deviations, complaints, root causes and CAPAs; monitoring production processes and identifying deviations from established procedures; reviewing SOPs, validation protocols, BMRs and other GMP documentation; participating in change controls, CAPAs, audits and compliance investigations; developing and implementing continuous improvement and quality improvement initiatives; providing recommendations regarding product safety, occupational health and environmental matters; delivering training and knowledge transfer and collaborating with Production, QA, QPs, Engineering and other stakeholders. Requirements include a Master's degree or equivalent academic working level, preferably in Pharmacy, Chemical Engineering or a related field; experience within the pharmaceutical industry and production environment; knowledge of (aseptic) pharmaceutical processes and production control systems; strong knowledge of GMP and Quality Assurance systems; experience with deviations, root cause investigations and CAPAs; experience reviewing SOPs, BMRs, validation protocols and GMP documentation; strong analytical, advisory, communication and reporting skills; excellent command of spoken and written English; ability to work effectively in a dynamic and demanding production environment; and a strong quality-oriented, collaborative and results-driven mindset.
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