Quality & Compliance Specialist

Sire Search; Haarlem; Vor Ort; EUR 60.000 - 85.000; Vollzeit

Zusammenfassung

Sire Search seeks a Quality & Compliance Specialist to support day-to-day production in Haarlem, working on deviations, investigations, CAPA follow-up, and documentation improvements to meet GMP standards.

You'll collaborate with production and quality teams, review SOPs and batch records, and ensure compliant records, investigations, and audit responses. Strong English skills and a Master’s level related degree are required.

Qualifikationen

• Master’s level degree in Pharmacy, Chemical Engineering, or related field.
• Experience in pharmaceutical production environments.
• Strong knowledge of QA systems and GMP documentation.
• Experience with deviation management, investigations, CAPA.
• Strong written and spoken English.
• Temporary 3-month full-time contract.

Aufgaben

• 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 audits.
• Review and support updates to SOPs, batch records, and related documentation.
• Ensure quality standards and GMP instructions are implemented and maintained in production.
• Support compliance investigations and audit responses where required.
• Provide knowledge transfer and deliver training to stakeholders.
• Participate in operational and quality meetings with key internal stakeholders.

Kenntnisse

Deviation management

CAPA

Root cause analysis

Quality assurance

GMP documentation

Stakeholder management

English communication

Ausbildung

Master’s degree in Pharmacy or related field

Tools

Documentation control tools

Jobbeschreibung

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.