06 ago
|
H.Essers
|
Italia
Are you ready to combine your passion for quality and logistics in the dynamic role of Responsible Person? Discover below the challenges and rewards that come with this role at H.Essers.
YOUR CHALLENGE
As an RP, you play a crucial role in ensuring the quality and safety of the pharmaceutical products we store and transport. You are responsible for the continuous improvement of the quality systems for pharmaceutical products within H.Essers and you function as a contact point to government agencies, to guarantee good quality to our customers.
What this means specifically:
In relation to GDP activities:
- Implementation and maintenance of the quality management system
- Management of authorized activities and the accuracy and quality of their records
- Implementation and maintenance of the training program
- Coordination and execution of any recall operations as requested and initiated by the customer
- Management of customer complaints
- Qualification of customers, suppliers and approval of subcontracted activities
- Management of the self-inspection program
- Documentation of the delegated duties, if any, and their duration
- Management of returned, rejected, recalled and falsified medicinal products, according to the final disposition decision of the customer
- Adherence to any additional requirements imposed on certain products by national law
- In relation to The Royal Decree of 06.09.2017 regulating narcotics and psychotropic substances.
YOUR TALENTS
- As described in the Royal Decree of 14 December 2006 on medicinal products for human and veterinary Use Art. 84, § 1-4 for QP, and Art. 95, § 2 for Responsible Person – Pharmacist or Master Degree in pharmaceutical sciences, physician or Master in medical sciences, or veterinary sciences, chemistry, biochemistry or biology
- 1 to 2 years’ experience in the distribution, secondary packaging and physical importation of medicinal products
- Knowledge of and training in EU GDP Guidelines (2013/C 343⁄01), EU GMP Gui
📌 Responsible Person (Italia)
🏢 H.Essers
📍 Italia