Details:
Quality Chemist required for a 12 month contract with a leading multinational Pharmaceutical client.
The Quality Chemist will support testing of finished product across a variety of techniques for the solid oral dosage, sterile and biologic product portfolio.
Must have worked in a GMP/GLP environment and knowledge of Regulatory requirements for testing and validation pertaining to the Pharmaceutical industry is required.
Responsibilities:
1. Review of analytical data and documentation to ensure compliance to appropriate specifications and protocols.
2. Supports reviews and investigations for out-of-trends/out-of-specifications.
3. Participates in validation and commercial/developmental manufacturing activities.
4. Troubleshoots standard instrumentation/test methods.
5. Working knowledge of Chromatographic separations in UPLC/HPLC and Empower.
6. Coordinates waste management, LEAN/Operational excellence and 5S efforts as required.
7. Participate in QC and cross-functional projects as required.
8. Assists in the training of QC staff.
9. Writes and revises methods, specifications, and SOPs as needed.
Experience
1. BSc degree in analytical Biochemistry or equivalent.
2. Prior experience in pharmaceutical industry is essential.
3. Chromatographic separations experience in UPLC/HPLC and Empower.
4. Technical writing (protocols, reports, procedures).
5. The ability to analyze data with a logical approach to problem solving and troubleshooting.
Quality Operations Process & Compliance Director
Location: Cork Role: Permanent
Quality Operations Process and Compliance Director with a leading Global Pharma Company. As part of a Global team, the Quality Operations (QO) Process and Compliance Director will be responsible for coordination and execution of QO Operating Process Compliance.
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