Beschreibung
Hallo liebes Netzwerk,für einen meiner Pharmakunden aus Hessen bin ich derzeit auf der Suche nach einem
freiberuflichen Senior Expert QA (m/w/d)
Main purpose:
- Perform a review and release of material dispatches.
- Support and perform a review and release of incoming material receipts in accordance with product / item specifications.
- Ensure to support that any activity (storage, additional labelling, quality control, distribution, returns, rejects and destruction) related to investigational medicinal products, medicinal products used in clinical trials / NPPs and starting materials is performed in compliance with European and regional regulations and Good Manufacturing/Distribution Practices, as needed.
- Support client audits and regulatory inspections and assist in preparation of audit report responses.
- Effectively interact with Operations and stakeholders to maintain that all QA tasks are appropriately supported by QA.
- Correct handling of the documentation related to Quality such as Receptions, Dispatches and Procedures, etc.
- Liaise with operations on all GMP related matters upon line manager's request.
- Write local quality assurance procedures and support as required for GMP Compliance of our CTD facility and contribute to Global Quality processes as required.
- Support the preparation of an internal audit schedule and support internal audits, if requested.
- Identify relevant GMP / quality related training needs and inform your line manager.
- Support process improvements within CTD Frankfurt.
- Support your line manager, that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management
- Support and after appropriate training manage receipts of non-medicinal supplies: ensure to support an appropriate level of control is performed by QA or QC personnel
Further Information:
- preferably 5 days a week on site, for the beginning 3 days possible
- start: immediately
- time schedule: ca. 3 months
- region: Frankfurt, Germany
Bei Interesse oder einer Kontaktempfehlung, freue ich mich über Ihre Nachricht. Senden Sie mir dazu doch bitte Ihren aktuellen Lebenslauf, Stundensatz sowie derzeitigen Verfügbarkeit.