Samira Koukene

A quality control engineer , results-oriented, technically sophisticated quality assurance and management professional with over 20 years of international experience in managing quality systems for pharmaceutical, biopharmaceutical, homeopathic as well as health products and enhancing overall manufacturing operations. Proven track record of spearheading challenging quality projects and minimizing complaints. Expert in devising, reviewing, and implementing quality compliance strategies/ action plans, operational upgrades, change controls, and continuous improvement methodologies to ensure compliance with corporate policies and quality standards such as European GMP, FDA, Health Canada. Well-versed in writing, updating and approving SOP’s, regulatory submission files, non-conformance investigations,OOS, CAPAs, discrepancy report, audits, supplier certifications, and quality documents management. Instrumental in leading and training teams, monitoring KPIs. Generating calibration, maintenance, qualification and validation program, protocols and reports. Instrumental in deploying improvement processes as well as allocating the departmental resources to achieve organizational milestones within strict time and budgetary constraints.

Engineering in Quality Control and Analysis with Concentration in Microbiology