QC Physicochemical Coordinator

Location
Poland
Salary
On Application
Posted
19 Nov 2018
Closes
19 Dec 2018
Ref
CWi
Discipline
Quality, QA / QC
Contract Type
Contract

What will you do? 

  • Manage QC team, motivate employees towards achieving the objectives set
  • Prepare, review and approve procedures, instructions and other QC's documents
  • Ensure performance of all necessary physicochemical tests and evaluation of related records
  • Timely release or reject tested intermediates, product in bulk and final product. Timely and reliable performance of analysis
  • Ensure performance of all appropriate method transfers and validations
  • Ensure maintenance and qualification of premises and equipment in the department
  • Ensure providing introductory and tailored-to-the-needs employee trainings
  • Participate in internal and external audits
  • Perform all duties with respect to current GMP requirements and other pharmaceutical regulations
  • Approve and monitor contract analysts and laboratories
  • Manage out-of-spec results, deviations and inconsistencies observed in manufacturing process and tests conducted by team members
  • Plan both own and subordinate employees’ work and progress reporting
  • Manage and supervise stability studies

What do we expect? 

  • Higher education with specialization in the fields like: chemistry, biotechnology, molecular biology, biochemistry, pharmacy, medicine or related
  • Practical and theoretical knowledge regarding transfer and validation of analytical methods, stability studies, liquid chromatography related to working with biological drugs (such as: peptide mapping, size exclusion, ion exchange), capillary electrophoresis, ELISA, UV-VIS spectrophotometry, pharmacopoeial methods used for release of raw materials, intermediates and final drug product
  • Min. 5 years of experience in regulated laboratory environment (biotechnological lab preferred). Very good knowledge of GMP and GDP rules
  • Very good knowledge of GMP and GDP rules and ability to implement and supervise compliance with these rules within a laboratory environment
  • Communicative knowledge of Polish & English
  • Good knowledge of MS Office
  • Very good ability to organize the work of a team and one’s own duties, ability to work under time pressure
  • very good cooperation with others in order to solve the problems
  • Keeping timelines, ability to prioritize tasks
  • Analytical thinking

 

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