Reporting to the Head of QA, the person in charge of the QC area, will be responsible Pilot Plant Lab and creating and developin a new QC area.

Duties:

• Schedule/manage routine and non-routine analysis of in-process samples, raw materials, finished products or stability samples.
• Manage the set-up and qualification/validation of analytical methods used in quality control, as well as the associated transfers.
• Manage subcontracted tests with external laboratories.
• Create/review the documentation associated with analytical techniques and other operational procedures in the Quality Control area.
• Control of laboratory stock and inventory.

• Create/review stability protocols and reports.
• Review and ensure the integrity of data generated in the laboratory.
• Conduct out-of-specification (OOS) investigations and address and manage deviations related to analytical procedures.
• Contribute to quality systems in laboratory activities related to Change Control, deviations, CAPA, audits, quality metrics.
• CoA review and approval.

Training
Degree in Life Sciences

Specific Training:

Protein and enzyme assays, Biochemistry and Molecular Biology analytical techniques (PCR, qPCR, nucleic acid extraction, agarose/polyacrylamide electrophoresis, WB, ELISA...), cell culture techniques (maintenance and establishment of cell lines, cell viability assays, proliferation) and general analytical techniques (preparation of calibration/quantification standards, preparation of stocks and reagents).

Other valuable knowledge:
GLP (Good Laboratoty Practices)
Development, Qualification and validation of analytical methods.
IQ/OQ/PQ of analytical equipment.