We are seeking a Quality Engineer to join our client's team within the bio/pharmaceutical sector. In this role, you will play a pivotal part in maintaining, optimizing, and supporting the Quality Management System (QMS) across product life cycles. You will work collaboratively with cross-functional teams to ensure manufacturing processes, products, and equipment comply with international cGMP standards, drive root-cause investigations, and ensure batch release readiness.
Key Responsibilities
- Deviations & CAPA Management: Lead non-conformance and deviation investigations across manufacturing operations, driving root-cause analysis (RCA) and implementing effective CAPAs to prevent recurrence.
- Risk Management: Facilitate and review Quality Risk Assessments (e.g., FMEA, PHA) for facility, process, and utility changes to maintain operational compliance.
- Change Control Support: Review and approve technical change controls, ensuring impact assessments are thoroughly evaluated from a quality and regulatory perspective.
- Batch Record Review & Quality Oversight: Provide daily quality support to production areas, reviewing executing records, in-process controls, and supporting batch disposition activities.
- Supplier & Internal Auditing: Conduct internal self-inspections and participate in supplier audit programs to evaluate partner quality systems and material compliance.
- Continuous Improvement: Lead and participate in quality improvement projects (using Lean/Six Sigma principles) to streamline processes and reduce quality cycle times.
Qualifications & Experience
- Education: Degree in Science, Chemical Engineering, Bio-Engineering, or a related technical discipline is essential.
- Experience: 3+ years as a Quality Engineer or Quality Specialist within a cGMP-regulated biopharmaceutical or pharmaceutical environment.
- Asset Advantage: Experience supporting aseptic processing, sterile fill-finish operations, or biological drug substance manufacturing is highly desirable.
- Core Competencies: Strong practical knowledge of EU GMP Annex 1, FDA regulations, ICH Guidelines (Q8, Q9, Q10), and ISO standards.
- Technical Skills: Proven experience with root-cause analysis methodologies (5-Whys, Fishbone, FMEA) and electronic QMS software (e.g., TrackWise, Veeva).
- Soft Skills: Exceptional problem-solving skills, strong technical writing capabilities, and the ability to effectively communicate across Engineering, Operations, and QA departments.
