Deviation Investigator

SIRE LIFE SCIENCES; Haarlem; On-site; EUR 33,000 - 60,000; Full time

Job summary

SIRE LIFE SCIENCES in Haarlem, Netherlands is seeking a Deviation Investigator to support a production organisation by managing deviations and leading quality investigations to timely closure.

The role focuses on quality-system investigations, requires strong analytical thinking, and collaboration with Production to ensure GMP-compliant documentation and CAPA follow-up.

Qualifications

• Proven experience in the pharmaceutical industry is required.
• Hands-on with deviations and investigations including root cause analysis.
• Strong documentation and GMP knowledge.

Responsibilities

• Write, manage, and coordinate deviations from start to closure.
• Lead quality investigations, define scope, gather evidence, document findings.
• Perform root cause analysis and support CAPA actions.
• Work with Production teams to clarify facts and keep investigations moving.
• Ensure investigation files are complete, traceable, and GMP-compliant.
• Review SOPs, batch records, and protocols to support decisions.
• Assist with quality-related questions and provide guidance on deviation handling.
• Contribute to continuous improvement from deviation trends and audits.
• Participate in meetings with cross-functional stakeholders on quality topics.

Skills

Deviations management

Root cause analysis

CAPA

GMP knowledge

Documentation

Independent worker

English fluency

Job description

Company

Our client is a global organisation operating in a highly regulated pharmaceutical manufacturing environment. The site combines production and quality expertise to ensure products are made safely, consistently, and in full compliance with GMP and internal quality standards. The culture values ownership, clear documentation, and practical collaboration between Quality and Production.

Job Description

We are looking for a Deviation Investigatorto support a production organisation by managing deviations and leading quality investigations to timely closure. The focus of this role is on quality-system investigations rather than routine production work. The successful candidate will be analytical, structured, and confident working independently while partnering closely with Production stakeholders.

Responsibilities

• Write, manage, and coordinate deviations from start to closure.
• Lead quality investigations, including defining scope, gathering evidence, and documenting findings.
• Perform root cause analysis and support the definition and follow-up of corrective and preventive actions (CAPAs).
• Work closely with Production teams to clarify facts, challenge assumptions when needed, and keep investigations moving.
• Ensure investigation files are complete, traceable, and compliant with GMP and internal quality standards.
• Review relevant documentation such as SOPs, batch records, and protocols to support investigations and decisions.
• Support quality-related questions from the production organisation and provide clear guidance on deviation handling.
• Contribute to continuous improvement initiatives based on deviation trends, audit observations, and investigation outcomes.
• Participate in meetings and collaborate with cross-functional stakeholders to ensure alignment on quality topics.

Requirements

• Proven experience in the pharmaceutical industry (mandatory).
• Hands-on experience with deviations and investigations, including root cause analysis and driving actions to closure.
• Strong understanding of GMP and quality systems, with a high standard for documentation.
• Ability to work independently, prioritise effectively, and deliver under time pressure.
• Strong communication skills and confidence working closely with Production teams.
• Professional English (spoken and written).
• Experience in sterile/aseptic manufacturing is a strong advantage.
• Temporary Full-Time Contract (3 Months)

Other Information

This role requires strong on-site presence, especially during the initial phase, due to the hands‑on nature of documentation and stakeholder interaction.