Quality & Compliance Specialist
Quality & Compliance Specialist voor een farmaceutische productieomgeving, on-site in Haarlem, tijdelijk fulltime contract (3 maanden).
- Locatie
- Haarlem
- Werkvorm
- op locatie
- Sluitingsdatum
Bekijk en reageer bij SIRE Life Sciences B.V. (externe link)
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Eisen
- Strong knowledge of quality assurance systems and GMP documentation practices
- Able to work effectively in a dynamic environment with shifting priorities
- Academic working and thinking level (Master’s level or equivalent), preferably in Pharmacy, Chemical Engineering, or a related field
- Good written and spoken English
- Experience within the pharmaceutical industry, ideally in or closely supporting a production environment
- Experience with deviation management, investigations, root cause analysis, and CAPA
- Strong communication skills with an advisory, stakeholder-focused approach
Volledige omschrijving
Our client is a leading organisation in the pharmaceutical manufacturing sector. They operate in a highly regulated environment and are committed to delivering safe, high-quality products through strong quality standards, continuous improvement, and a culture where compliance and collaboration are key. We are looking for a Quality & Compliance Specialist to support day-to-day production by ensuring activities are performed in line with GMP requirements and internal quality standards.
The role focuses on deviation support, investigations, CAPA follow-up, and strengthening documentation practices across manufacturing and packaging operations.
Responsibilities include: support manufacturing and packaging teams with deviations and quality-related questions; assess deviations and advise whether production activities should be paused or stopped when needed; monitor production processes and identify deviations from established procedures; investigate and document deviations and complaints, ensuring clear, compliant records; perform and document root cause investigations and drive CAPA actions to closure; propose and support improvements to production methods, processes, and product quality; contribute to continuous improvement initiatives, including actions from internal/external audits; review and support updates to SOPs, batch manufacturing records, and related documentation; ensure quality standards and GMP instructions are implemented and maintained in the production environment; support compliance investigations and audit responses where required; provide knowledge transfer and deliver training to relevant stakeholders; and participate in operational and quality meetings with key internal stakeholders.
Requirements include: academic working and thinking level (Master’s level or equivalent), preferably in Pharmacy, Chemical Engineering, or a related field; experience within the pharmaceutical industry, ideally in or closely supporting a production environment; strong knowledge of quality assurance systems and GMP documentation practices; experience with deviation management, investigations, root cause analysis, and CAPA; strong communication skills with an advisory, stakeholder-focused approach; good written and spoken English; and ability to work effectively in a dynamic environment with shifting priorities.
This is a temporary full-time contract of 3 months duration, based on-site in Haarlem, Netherlands. The selected candidate will work closely with a range of internal stakeholders across production, quality, and technical teams and will play a key role in maintaining compliance and driving improvement.
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