Deviation Investigator
First seen by Alion on Sep 11, 2026. SIRE Life Sciences scores B on the Alion truth index.
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 Investigator to 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.
If you are interested and want to apply, please submit your application via the apply button below and contact me.
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