
Laboratory Specialist
4 days ago
KLEVA Pharmaceuticals S.A. is a privately owned pharmaceutical and fully integrated company that has been in operation for over 50 years.
We develop and manufacture generic products, focusing on Pharmaceuticals (Rx & OTC).
Our mission is to offer a flexible, scalable, qualitative, and cost-effective product development in various dosage forms.
To achieve our goals, we need innovative individuals who respect cooperation and are ready to commit to a company that wants to penetrate new markets and leverage international business opportunities.
How You Will Support Our Mission
We are looking for a Quality Control Specialist.
Responsibilities:
- Ensure lab cleanliness and safety standards are maintained. Develop and qualify new testing methods.
- Train other analysts to perform laboratory procedures and assays. Participate in internal and external audits as required.
- Identify and troubleshoot equipment problems.
- Evaluate new technologies and methods to make recommendations regarding their use.
- Serve as a technical liaison between quality control and other departments, vendors, or contractors. Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses.
- Supply quality control data necessary for regulatory submissions. Receive and inspect raw materials.
- Review data from contract laboratories to ensure accuracy and regulatory compliance.
- Prepare or review required method transfer documentation including technical transfer protocols or reports. Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
- Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
- Identify quality problems and recommend solutions.
- Evaluate analytical methods and procedures to determine how they might be improved.
- Bachelor's degree in Chemistry
- Postgraduate degree is desirable
- 1+ year of related pharmaceutical laboratory experience in a cGMP environment
- Prior experience in method development/validation and/or transfer/verification, protocols, and troubleshooting
- Fluency in the English language written and oral
- Work in a friendly and challenging environment
- Competitive salary
- Private insurance
- Personal development opportunities
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