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QC Physicochemical Coordinator

Europe, Europe

  • Salary: Up to €6,000 per month
  • Job type: Interim/Contract
  • Posted: 19/11/2018
  • Contact name: Christopher Wise
  • Contact number: 01892 612612
  • Ref: 3770

Job description

Quality Control Physicochemical Coordinator

Poland - Polish & English Speaking Required

12 month contract with option to extend or go permanent

 

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