Qualified Person – Pharmaceutical Industry (QP)

  • Full Time
  • Bucuresti
  • This position has been filled

Qualified Person – Pharmaceutical Industry (QP)

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 2 years and submitting them to the competent authorities when required;
  5. Coordinates and ensures the implementation of emergency plans by working in cooperation with the Radiation Safety Officer in order to ensure that production activities are managed in accordance with Radiation Safety rules;
  6. 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.
  7. Be responsible for ensuring and keeping confidentiality of documents and data he/she works with;
  8. Controls the standards regarding quality, the rules, regulations and legislative acts issued by specialised entities;
  9. Ensures that the materials and services affecting product quality are compliant at all times by ensuring the application in the suppliers in the same quality system manner;
  10. Works in collaboration with Quality Manager and Registration& Pharmacovigilance Manager;
  11. 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.
  12. Works in coordination  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;
  13. Prepares and approves the standard operation procedures, instructions, quality documentation including technical agreements, specifications, validation protocols and reports, change protocols, GMP deviations and customer complaints.
  14. Reports data on reactions and/or safety issues to Qualified Person Responsible for Pharmacovigilance (QPPV) of the marketing authorization holder.
  15. Performing necessary application and reports to the relevant authorities (National Drug Agency)
  16. Performing effective communication with the authorities regarding inspection, submission and renewal of the authorizations.

What the ideal candidate would look like?

  • Minimum of 5 years working in the pharmaceutical industry in a quality management position.
  • Operational GMP/QP experience
  • Solid knowledge of relevant legal requirements/applicable regulation of the pharmaceutical industry
  • Ability to work with autonomy and handle complex/difficult situations.
  • Good interpersonal, verbal, and written communication skills.

Please send your CV to the following e-mail address: recrutare@abchumancapital.ro

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Author: admin