Join our global quality team where you will be responsible for providing active ingredients that meet the highest pharmaceutical regulatory and compliance standards. You will achieve, together with your colleagues in Quality Assurance, Quality Control, Regulatory and Quality Systems, the delivery of a resilient supply of quality products to our clients.
This opportunity is for a QA product specialist to join the Quality Assurance Team for a fixed term contract with an immediate start.
Your Responsibilities
You will:
* Reporting directly to the Quality Assurance Manager, ensures the Batch record review for fermentation, utilities, finished products and intermediates. Coordinates the investigation of product quality concerns (Deviations, OOS and OOT) and the follow up of the related CAPAs. Support the investigation and CAPAs definition of complaints. Checks the content of the “Master Batch Production Records” and Operating Manuals and the compliance with the good manufacturing standards, site procedures, technical documentation filed and approved by the relevant Health Authorities, HSE and company policies and directives.
* Support the preparation of Product Quality Reviews (PQR’s); monitors the corrective and preventive actions (CAPA) for continuous improvement of the quality of production, packaging and processes robustness.
* Support the preparation of inspection visits (Regulatory Authorities, Customers). Participates in inspection visits and contributes to the implementation of any corrective actions.
* Support the conduction of programs related to the compliance of the Good Manufacturing Practices (GMP).
* Disseminates the Quality culture in the production departments providing the necessary specialist assistance for the implementation of specific programs of processes and performances improvement.
Our Requirements
* Scientific degree: degree in Biotechnology, CTF, Chemistry, Biochemistry. Previous experience in QA, QC and/or Fermentation Plants.
* Consolidated experience in cGMP pharmaceutical environment.
* Good knowledge of cGMP application.
* Knowledge of the Office package.
* Knowledge of IT tools used in pharmaceutical environment for the management of GxP activities (i.e. SAP).
* Knowledge of English at least medium level: both spoken and written.
* Motivation and sensitivity towards all aspects relating to Good Manufacturing Standards.
* Ability to work in team and to establish open and collaborative human relationship.
* High determination on results achievement and target accomplishment.
* Flexibility and strong adaptability.
Apply Today!
Find out more about this exciting opportunity, apply today!
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