مدیر کنترل کیفیت

ماکوفارما فردآور کرج

منتشر شده 1 سال پیش

Job Description

  • To ensure that the appropriate analytical validations and verification, calibrations and qualifications are performed.
  • To write and approve specifications, sampling instructions, test methods and any other quality control procedures.
  • To ensure that GMP and GLP are followed in the laboratory.
  • To ensure the appropriate approval or rejection of starting materials, packaging materials, intermediate, bulk, and finished products and provide the certificate of analysis.
  • To manage the procedures for the investigation of OOS and OOT and risk assessment
  • To define and set individual and collective objectives (KPIs) for the department, cascaded down from the general department objectives, within the performance review process.
  • To take part in complaint investigations together with the relevant department managers and issue a report
  • To report directly to the qualified person.

Requirements

  • Pharmacist.
  • 2 years of experience in a similar position.
  • Working knowledge of GMP and GLP and quality system requirements.
  • Ability to manage the relevant subsets and personnel.
  • Strong decision-making skills and a results-driven approach.
  • Working knowledge of relevant FDA, EU, ICH, and PICs guidelines and regulations.
  • Familiar with risk management methods.
  • Proficient in English.
  • Good knowledge of MS Office (Word, Excel, PowerPoint, Access, Visio, etc.).

If you are interested in this offer, please send us your CV.

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