Raw Materials Quality Specialist
Vor 4 Tagen
We are seeking a dedicated Raw Materials Quality Specialist to join our team focused on quality control within the Primary Packaging and Raw Material sector.
This role involves executing incoming goods control testing of raw materials, including consumables, excipients, and primary packaging, to support drug product manufacturing. You will manage specifications, testing, and release of raw materials for clinical and commercial production.
Responsibilities:- Receive and report results from external laboratories into the electronic system, assessing them against specifications and historical data.
- Perform assessments of testing requirements for raw materials against compendial and internal standards.
- Support laboratory investigations in collaboration with external testing laboratories.
- Author and revise specification sheets and manage associated change documentation.
- Compile data for reports and presentations, interpret data, and draw conclusions.
- Author and approve reports and standard operating procedures.
- Work on initiatives to improve process efficiency.
Key Skills and Requirements:
- Background in chemistry or related science field, with experience in the pharmaceutical industry.
- Understanding and application of cGMP concepts.
- Practical experience with analytical testing methods and instruments for raw materials.
- Strong problem-solving and analytical skills.
- Effective communication skills, both verbal and written.
- Proactive attitude and excellent teamwork skills.
- Experience with Raman, NIR/FTIR Spectroscopy is advantageous.
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