Qualified person – pharmaceutical field

  • Bucuresti
  • This position has been filled

Qualified person – pharmaceutical field

JOB DESCRIPTION

  1. Manages all the process from beginning of production processes to release of products and decides on „product release” in accordance with GMP requirements.
  2. Certifies each batch of finished product before release for sale and verifies the manufacturing records of the product series, issues the conformity certificates which are recorded in the „Register of Batch release” and archives them together with the manufacturing files of the product batches.
  3. Provides statement and certifies that each batch of drug product has been manufactured and checked in accordance with legal regulation including the requirements of its marketing authorisation and registration documentation.
  4. Responsible for the approval of manufacturing records for series and for keeping such records at a certain point for at least 5 years and submitting them to the competent authorities when required;
  5. Ensures that the quality system is maintained and updated at all times in accordance with the changing requirements, assures any inspection issues raised from internal or external bodies are comprehensively resolved by taking part in the implementation of corrective actions.
  6. Be responsible for ensuring and keeping confidentiality of documents and data he/she works with;
  7. Controls the standards regarding quality, the rules, regulations and legislative acts issued by specialised entities;
  8. Ensures that the materials and services affecting product quality are compliant at all times by ensuring the application in the suppliers is the same quality system manner;
  9. Works in collaboration with Quality Manager and Registration & Pharmacovigilance Manager of the company while coordinating customer complaints process and providing feedback to those customers;
  10. Ensures that the batch has been manufactured and checked in accordance with the requirements of marketing authorization, the principles and guidelines of Good Manufacturing Practices and all other required regulations, legislation, and licensing terms in effect.
  11. Works in coordination with the Quality Manager to ensure that an effective pharmaceutical quality management is implemented in accordance with the regulatory obligations of the marketing authorisation holder are fulfilled in order to release the batches and the quality certificates;
  12. Prepares and approves the standard operation procedures, instructions, quality documentation including technical agreements, specifications, validation protocols and reports, change protocols;
  13. Reports data on adverse reactions and/or safety issues to Qualified Person Responsible for Pharmacovigilance (QPPV) of the marketing authorization holder.

 

REQUIREMENTS

  • Having Bachelor’s Degree in Pharmacy
  • Being fluent in English.
  • Having 5-10 years pharmaceutical industrial experience
  •  Being familiar with all aspects of the GMP
  • Having a QP certification

Please send your resumes at: corina.diaconu@abchumancapital.ro

Author: admin