Senior Supplier Quality Engineer
Our client a leading pharmaceutical company based Cork requires a Senior Supplier Quality Engineer for a contract role.
- Provide overall quality assurance leadership in the management of select contract manufacturing sites engaged in the production of pharmaceutical products.
- Provide complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes.
- Utilize multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), and international organization for standardization (ISO).
- Report on contract manufacturer performance metrics.
- Provide Quality Engineering support to suppliers including audits/assessments, inspection technique support, verification/validation activities, CAPA and change management.
- Ensure External Manufacturers continue to meet Quality requirements with regard to Supplier Change Request process of the company
- Promote continuous improvement and Process Excellence activities within the Global Supply Chain
- Resolve problems & eliminate constraints to ensure project and supply targets are met.
Education, Experience and Skills:
- A minimum of a Bachelor's degree is required, preferably in an Engineering, Life Science, or related discipline.
- A minimum of 6 years of experience in a highly regulated industry is required.
- Experience in the Medical Device industry and/or Pharmaceutical industry is required.
- FDA and ISO regulations knowledge is required, with FDA CFR Part 820 and ISO 13485 knowledge required.
- Auditing background is an asset.
- Experience in root cause analysis is required.
- Six Sigma, Lean, or ASQ Certification and trainings an asset.
- This position will require travel
- Non Technical Skills and Additional Details
For further information on this Quality Job in Cork please contact Bimi Felix on 091 730022/ email@example.com
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