Quality Control Laboratory Manager Ne

Quality Control Laboratory Manager
Ne
Liguria, Ne

QUALITY CONTROL LABORATORY MANAGER EXPERIENCE Over five years of experience in the role in pharma.

Professional background:

Biopharma/pharma companies.

EDUCATION Master Degree in chemistry, pharmaceutical chemistry/science, biotechnology or equivalent.

QUALIFICATION PROFILE Strong and well-established background and hands-on experience in method validation in compliance with regulation:

ISO 17025, ISO 13485, GMP.

Coordinating and supervising execution team (timing and deliverables):

in the field of development, validation and transfer of chemical and mechanical methods.

Coordination and supervision of activities related to the lab Quality assurance/control and QA functions support.

Well-established knowledge of analytical laboratory equipment Experience inconducting third party and authority audits (Accredia, AIFA, FDA etc. ).

Experience in coordination and management of stability studies in compliance with ICH guidelines, GMP e GLP (Stress/accelerated testing, stability testing, shelf-life studies).

Knowledge and experience in instrumental management software (i. e. , Empower) and LIMS system for the management of the lab automation.

Specializing in authoring/reviewing high-quality scientific documents including SOPs, quantification/validation protocols, analytical investigation, laboratory deviation, and comprehensive analytical reports (Experience in performing investigation for OOS/OOT results, CAPAs) Experience in supervising and performing IQ/OQ/PQ protocols, calibration and maintenance of analytical instruments.

Experience in handling and management of hazardous materials and controlled substances.