QA Manager (Remote) - Part-time - 6 Months

Part-time - 6 Months - Munich - 16-10-2019 zur Vakanz  

A Multinational Pharmaceutical Client of mine are currently looking for a Quality Assurance Manager to join them on a part-time contract basis for 6 months working remotely with occasional site visits within Germany.

 

Key tasks/responsibilities:

  • Writing of validation reports foranalytical methods for control of client development projects (respiratory and solid oral products). The assignment includesfamiliarization with method validation documentation and results, and writing the method validation report in the required format. Test parameters in scope are as follows
  • Identification/assay/degradation products by High Performance Liquid Chromatography coupled with Ultraviolet detection (HPLC-UV) 
  • Degradation products by HPLC-UV or Ion Chromatography (IC) 
  • Content of functional excipients (HPLC-UV) 
  • Content uniformity, uniformity of delivered dose, spray content uniformity (HPLC-UV) 
  • Respiratory test parameters like aerodynamic fine particle dose, dynamic particle size distribution and fine particle dose (Andersen cascade impactor and laser diffraction) 
  • Dissolution (paddle/basket, UV/HPLC-UV)
  • Monitoring and reporting of contact and in-use stability studies for respiratory products running internally as well as externally. The assignment includes
  • Drafting a stability protocol, 
  • Check of test results
  • Trouble shooting, 
  • Handling of quality events, 
  • For course audits and reporting
  • On-site visits at sites across Germany may be necessary to properly plan and monitor the stability studies. 
  • Translation of German templates for validation protocols to English

Minimum Requirements:

  • Mast in Chemistry or Pharmacy or Equivalent training
  • Experience in Quality Control of Pharmaceuticals
  • Experience in respiratory dosage forms appreciated
  • Technical/regulatory writing skills
  • Fluent in German and English
 

Vacancy Summary:

Job Type: Contract
Hours: 12-16 hours per week
Duration: 6 Months
Location: Remote
Salary: Negotiable (DOE)
 
If you are interested in this role or know anyone who might be please forward on your most up to date CV and I’ll be in touch shortly to discuss further. Alternatively you can give me a call on +44 (0) 207 324 1910.

 

****As always Referrals are much appreciated****

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