Qualified Person - Denmark
Want to know company name or location? Company managed [?]
Our fast growing Quality Assurance Department is looking for a QP who will ensure that all the activities during the secondary packaging have been performed according to the cGMP rules.
- Adhere to and ensure compliance with company policies and procedures related to secondary packaging.
- Ensure that products meet the required standards various elements of current Good Manufacturing Practices (GMP).
- Ensure that every batch of medicines manufactured on site are produced, examined and stored according to the relevant legislation and marketing authorizations.
- Operating and maintaining our quality management system.
- Write, revise and approve SOPs.
- Quality process improvement.
- Monitoring, enforcement and compliance of the pharmaceutical standards (GMP, GDP).
- Supervise deviation, complaint and change control management.
- Interaction with public authorities, representation of the company, data service for OGYÉI.
- Corrective and preventive actions (CAPA) management.
- Participation in internal and external audits (supplier, outsourced activities).
- Participation in project implementations and IT validation projects.
- Review and approve qualification documents.
- Control that all the employees of our company Hungary receive the necessary training regarding to GMP.
- 5 years+ relevant pharmaceutical industry experience in a GMP environment.
- QP will work in an international environment.
- He/she has to communicate spoken and written on a daily basis with colleagues in The Netherlands and Denmark, proficiency in English and in Hungarian is a must.
- For a smooth cooperation QP needs to have excellent communication skills to be able to cooperate with all the level of the organization in Hungary, Netherlands and Denmark.
- Depending on the workload, QP has to be flexible, occasionally willing to work on weekends.
- The positions requires average user level of computer skills.
- your interest and background meets with our expectations
- you have strong communication skills
- you are a self-made and pro-active person
- you have strong quality mindset
- you are able to do multi-tasking
- you would like to be a member of a young and dynamic organization