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Cephas Consultancy Services Private Limited is seeking a highly skilled QC Analyst to join our team in Bilthoven, Netherlands.
The Role
We are looking for a detail-oriented and organized individual to ensure compliance with Current Good Laboratory Practices as laid down in the Quality Control Procedures.
Key Responsibilities
- Ensure the maintenance of laboratory working areas and follow safety precautions while working in the laboratory.
- Perform analysis of finished products and review intimation documents for details.
- Organize work to complete testing within stipulated time and be aware of potential problems that could occur during the testing process.
- Ensure the use of instruments/equipment meeting established performance specifications and are properly calibrated.
- Follow correct analytical techniques during preparation of solutions and follow specific instructions/precautions provided based on material/product characteristics.
- Perform testing of samples as per procedure specified in specification and make concomitant entries in test data sheets.
- Set parameters of instruments as given in specification and ensure compliance of system suitability parameters before commencing for sample analysis.
- Follow cGLP for documentation and ensure that figures for quantitative tests are rounded to the number of decimals indicated in the standards of specification.
- Promptly report abnormal observations of OOS, OOT, analytical incidences, instrument malfunctioning, etc., or obvious errors occurred during preparation to the section Head.
- Ensure completeness of entries of all the tests performed and completion of relevant data before submission for review.
- Involve in the investigation of OOS, OOT, or analytical incidences and disposal of balance samples after completion of analysis and review.
- Perform analysis using various instruments/equipment available in the lab and calibration of instruments/equipment, preventive maintenance, and validation as per specified schedule.
- Maintain records of schedules, calibration, history files, preventive maintenance (in-house and outside), and validations.
- Handle breakdown of instrument/equipment as per procedure and follow up with service engineer for rectification.
- Discontinue and withdraw faulty or not in use instruments/equipment from usage.
- Maintain stock/regeneration/washing of HPLC columns properly and maintain glassware, chemicals/reagents, and stationary items properly.
- Prepare and review different QC documents and perform any other assignment allocated by the Head Quality.
Ideal Profile
- Should be a Bachelor's/Master of Science in Chemistry with experience and working knowledge of CGMP regulations.
- Key Skills - Fluent English language is required.
What's on Offer?
- Work in a company with a solid track record of performance.
