
Raw Materials Quality Assurance Expert
1 day ago
We are seeking a highly skilled Quality Control Specialist to join our team in ensuring the quality of raw materials used in pharmaceutical production.
About the Role:
- Perform Analytical Testing: Conduct analytical testing of incoming raw material samples using compendial methods such as FTIR, wet chemistry identity testing, etc.
- Manage Sample Receipt: Manage sample receipt, storage, and reagent preparation according to cGxP requirements.
- Conduct Method Validation: Conduct raw material method validation/verification and routine release testing.
- Document Analytical Activities: Document analytical activities in compliance with GMP, HSE, and data integrity standards.
- Support Stability Testing: Support stability testing and associated sample management when applicable.
- Participate in Laboratory Investigations: Participate in laboratory investigations (OOS, deviations) and support related change controls.
- Maintain Laboratory Compliance: Maintain the QC Raw Materials laboratory in full cGMP compliance and support audits/inspections.
- Contribute to Continuous Improvement: Contribute to continuous improvement projects within the QC laboratory.
Requirements:
- Academic Background: Degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or equivalent scientific field, or completed apprenticeship as a laboratory technician.
- Experience: 3 to 5 years of experience in pharmaceutical laboratory environments (quality control, quality assurance, or production).
- Skills: Experience with analytical testing of raw materials (FTIR, wet chemistry identity tests, reagent preparation), knowledge of GMP and cGxP compliance requirements, and experience with data entry, review, and preparation of QC release packages.
- Personal Qualities: Collaborative, result-oriented, and demonstrates strong problem-solving and organizational skills.
About Our Company:
We are committed to excellence and innovation in our work. We believe that our employees are our greatest asset, and we strive to create a work environment that is stimulating, rewarding, and supportive.
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