Quality Control Manager – pharmaceutical field

  • Full Time
  • Bucuresti
  • This position has been filled

Quality Control Manager – pharmaceutical field

  1. Manages and is responsible for the safety performance of all activities
  2. Is responsible and organizes the control on the following of the requirements and the rules for physical safety, as defined at juridical acts and internal documents
  3. Ensures the organizing and functioning of the Quality Control Department and is responsible of the efficient management and the execution of all quality control analyses within the laboratory of the Quality Control efficiently and productively
  4. Ensures the completion of all tests related to quality control of chemical and microbiological analysis of primary materials, the packaging materials, intermediary and final products, according to GMP, GLP, GRP, the approved documents, the Radiation and Occupational Health Safety rules and environmental rules reporting, evaluating and recording these test into system
  5. Takes part in implementing the corrective actions established by internal and international quality audit and actions for solving the incompliant product, of the complaints, of product recalls, and of deviations and ensures the cooperation with the other departments in order to eliminate quality deficiencies
  6. Ensures the necessary conditions for the usage of the quality control laboratories, devices and equipment according to the GMP, GLP, GRP requirements and report to his/her manager when necessary
  7. Plans, executes, and/or ensures the calibration, validation activities within the Quality Control Department along with the qualified person
  8. Takes part in the validation activity of the technological processes, of the analytical methods, as well as in the validation activity for the cleansing of the equipment, spaces, tools, along with the representatives of the departments involved in this activity
  9. Takes part along with the representatives of the Quality Assurance and Production Departments in the validation of the suppliers and manufacturers of raw material and packaging material
  10. Prepares or ensures the preparation of SOP, instructions, specifications, methods and device information sheets regarding quality control laboratory activities, to keep relevant SOPs up to date, to ensure that recording forms in use are up to date
  11. Develops new analysis methods. Instructions, specifications and methods, executes or ensures the execution of the methods validation
  12. Takes a continuous process of self-training and takes part in the trainings related to the carried activity according to GMP
  13. Guarantees that the department personnel receive the required orientation and continuous trainings, and that revisions are made in accordance with requirements
  14. Approves and monitors any contract analysts.

 

Requirements

  1. ·  Having Bachelor’s Degree in Chemistry/Chemical Engineering/Pharmacy
  2. ·  Being fluent in English
  3. ·  Having minimum 2- 3 years of experience at pharmaceutical companies in Quality Control.

Please send your CVs to the following email address: corina.diaconu@abchumancapital.ro

Author: admin