QC MANAGER (R&D MEDICAL DEVICE)


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.

QUALIFICATION PROFILE
  • 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.)

REQUIREMENTS:
  • 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.
Business unit
Quality Unit
Sedi
Italia/Veneto

CONTATTI

Pharma Point Srl - Foro Buonaparte, 48 - 20121 Milano, Italia

Email: info@pharmapoint.it - Tel. +39 02-89013167

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