SPECJALISTA DS. ZAPEWNIENIA JAKOśCI / QA SPECIALIST (m/w)
Stryków
About our client
Our client is leading pharmaceutical company with international range currently employing more than 10000 people worldwide and being present in more than 100 countries. The main goal of the company is to keep production on the highest quality level.
Due to the company\'s fast growth in Poland, we are currently looking for the most suitable candidate for the position of Manufacturing Technologist.
The person on this position would be responsible for keeping the highest quality standards and report to the Quality Assurance Manager.
Job description
The main objective on this position is to prepare the organisation for the FDA audit (audit of Food and Drug Administration). This role will enable you to be part of developing and implementing the quality assurance programme for the production, business, challenging and improving current GMP (Good Manufacturing Practice), so that all necessary requirements of production on American market will be fulfilled.
Your responsibilities will include:
- Creating, verifying and implementing instructions and procedures for medicinal products assuring production compliance with registration documents
- Inspection/control and follow-up of manufacturing to improve the quality
- Taking part in creating, verifying and implementing risk assessment
- Review Manufacturing and Quality documents to facilitate QP release of medicines to market
- Initiating, evaluating as well as implementation and supervision of mending actions in case of incompatibility with quality standards and as a result being part of a team responsible for undertaking preventing actions
- Execution of the internal and external audits to confirm and improve compliance with the regulatory requirements
The role offers an excellent opportunity to have a great influence on creating quality assurance process in the company.
Who we are looking for
The ideal candidate will demonstrate:
- At least 2 years of current or previous experience in Quality Assurance gained within the Pharmaceuticals Industry
- High degree of education preferably in pharmacy, chemistry, biology, biotechnology, process or chemical engineering
- Experience in previous companies in the area of FDA audit preparation or execution
- Proven experience within Internal/External Audit
- Knowledge of SAP system preferred but not essential
- Excellent communication skills both in Polish and English
- Ability to be flexible in a fast changing environment
We offer:
Our client is leading pharmaceutical company with international range currently employing more than 10000 people worldwide and being present in more than 100 countries. The main goal of the company is to keep production on the highest quality level.
Due to the company\'s fast growth in Poland, we are currently looking for the most suitable candidate for the position of Manufacturing Technologist.
The person on this position would be responsible for keeping the highest quality standards and report to the Quality Assurance Manager.
Michael Page Contact
Job ref: WRHB6099