Quality & Compliance Specialist
SIRE® Life Sciences
Quality & Compliance Specialist
Samenvatting
Wat krijg je?
Wat ga je doen?
- Support teams with quality-related deviations
- Advise on pausing production activities
- Investigate and document compliance deviations
- Execute root cause investigations and CAPAs
- Propose improvements to production methods
Wat verwachten wij?
- Academic degree in Pharmacy or Chemical Engineering
- Experience in the pharmaceutical production industry
- Knowledge of quality assurance and GMP documentation
- Experience with deviation management and root cause analysis
Volledige vacaturetekst
This role at a leading pharmaceutical manufacturer offers a dynamic environment where you ensure top-tier quality standards. You will focus on deviation support and root cause investigations within a culture of continuous improvement. The position provides a unique opportunity to work on-site in Haarlem, collaborating with expert teams to refine SOPs and drive impactful CAPA actions. Take this chance to sharpen your GMP expertise and make a tangible impact on production excellence. Dive into the full details to see how you can contribute!
Company
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.
Job Description
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
- 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.
- Participate in operational and quality meetings with key internal stakeholders.
Requirements
- 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.
- Able to work effectively in a dynamic environment with shifting priorities.
- Temporary Full-Time Contract (3 Months Duration)
Other Information
This position is 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.
If you are interested and want to apply, please submit your application via the apply button below and contact me.
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