5 days ago
Hamlyn Williams have partnered up with a large pharmaceutical company based in Munich, they are actively looking for a experienced Responsible Person to join their team on a permanent basis. This company is at a very exciting stage increase of production. This role would be working as a Responsible Person on their products.
The position will act as the Responsible Person named on the whole sale license of the PCC DE GMbH. You will be Approving commercial and technical contract/agreements between the Contract Giver and Acceptor related to respective responsibilities for GMP- manufacture, testing, packaging and GDP - wholesale distribution and/or transportation of medicinal products.
Responsibilities include but are not limited to the following:
- Taking part in the change control committee and Quality Management Review meetings.
- Participating to all company GDP and PV training in accordance with the training plan.
- Approving the initial and continuous training programme for all personnel involved in GDP and medicinal products distribution activities.
- Participating into any recall operations of medicinal products in accordance with the approved SOPs within the company.
- Assessment, review and release into saleable stock of medicinal products following certification by the Qualified Person.
- Overseeing the qualification and approval of suppliers and customers.
- Assessing and authorising the return to saleable stock or destruction of any returned medicinal products.
- Support the management and the Head of Quality EU to ensure compliance with GDP and approvals.
- Carrying out internal audits. Participation in audits within the scope of supplier and service provider qualification.
- Attend and participate in local and global management review meetings with stakeholders at management level
If this role could be of interest or you have any questions, don’t hesitate to get in touch!
020 8068 5235