Non Conformance Specialist

As a Non-Conformance Specialist within the Separations QC department of a pharmaceutical company, you are responsible for performing, documenting, and managing non-conformances in accordance with GMP and regulatory requirements.

What you will do.

• Lead investigations related to testing of raw materials, in-process materials, drug substances and drug products.
• Conduct root cause analyses using structured tools such as Fishbone, 5 Whys and KT analysis.
• Define, coordinate and implement corrections, corrective and preventive actions (CAPAs) and effectiveness checks.
• Assess the potential product quality and compliance impact of non-conformances and provide recommendations on product disposition.
• Maintain accurate and well-organized records for internal and external audits and inspections, and act as Subject Matter Expert (SME) during these activities.
• Work closely with cross-functional teams including Quality Assurance, Manufacturing, PQM, DPDS and Regulatory Affairs to resolve quality issues and ensure compliance with FDA, EMA, ICH and cGMP guidelines.
• Monitor and analyse trends in non-conformances and contribute to periodic trend reports (e.g. OOS/OOT).
• Contribute to training programmes related to non-conformance management for internal staff.
• Support continuous improvement initiatives and help optimise quality systems and workflows.

What they ask

• Bachelor's or Master's degree in Chemistry, Biology, Pharmaceutical Sciences or a related scientific discipline.
• Minimum of 3 years (MSc) to 5 years (BSc) of experience in Quality Control, Quality Assurance or a related field within the pharmaceutical industry, with a demonstrable focus on non-conformance management and investigation.
• Prior hands-on experience with NCs, CAPAs and ACTs relating to laboratory issues is essential.
• Familiarity with HPLC and/or separation techniques is a strong advantage.
• Solid understanding of GMP regulations, FDA and EMA guidelines and quality control best practices.
• Strong analytical and problem-solving skills, including experience with root cause analysis methodologies.
• Proficient in quality management systems (QMS) and investigation tools.
• Strong written and verbal communication skills in English.
• Proactive, detail-oriented and able to prioritise effectively while maintaining high quality standards.