Pharma point on behalf of multinational company is looking for a
QC MANAGER (R&D Medical Device)
The function is responsible for coordinating and supervising the team in the field of development, validation and transfer of chemical and mechanical methods.
- Well-established knowledge of analytical laboratory equipment
- Experience in conducting 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.
- Expertise in analytical techniques/methodologies such as:
- Physical and chemical separation techniques
- Inorganic element analysis (ICP-OES, ICP-MS and IC)
- Chromatography (GC-MS /HPLC-UV/MS etc.)
- Strong and well-established background and hands-on experience in method validation in compliance with regulation: ISO 17025, ISO 13485, GMP.
- Over five years of experience in the role in pharma or medical device (R&D).
- Master Degree in chemistry, pharmaceutical chemistry/science, biotechnology or equivalent.