Qualified Person QP - GERMANY Remote - Freelance Contract - 20-40 hours per month

Simon Trebilcock at Planet Pharma is proud to be exclusively recruiting for a Freelance Qualified Person QP for a client based in Dusseldorf, Germany. The company will be applying for a MIA for a stable blood product falling under article 15(3) of German law. The position can be conducted remotely, from home, if required. The company are looking for a German and English speaker for 20 – 40 hours per month for an ongoing (unlimited) period of time

Job Description

This is a freelance fully remote project starting in August 2021. The project will initially require 1-2 days per week in preparation for the Health authorities inspection and around 20-40 hours per month after the inspection.

As a QP, you will be named on customers MIA. The work is independent but requires strong collaboration skills both with customers and in cross-functional company group teams.

In your role as QP, you will provide strategic advice, project management, auditing, tech transfers and qualifications/validation support to your customers. QP support for local QMS. You will act as a project lead MIA-applications including writing the QMS, application to the competent authority, and then be named QP/RP. 

Responsibilities will include:

• Being named as QP on the MIA license as accepted by the Dusseldorf authority for blood products (Art 15(3) of German law)
• Release of blood products (article 159(3) of German law)

Qualifications

• A University degree in Science/Engineering is required, preferably MSc in Pharmacy or similar.
• 5-8 years’ experience working in QA in a GMP environment, preferably as QP or RP.
• Experience from CMC, auditing, IMPs, GCP, GDP, Medical Devices, biologics, and sterile/aseptic manufacturing is an advantage.
• The work requires excellent communication skills (oral and written).
• Experience with local Dusseldorf authority inspections and MIA-licenses.

This position has been highly popular, and it is likely that it will close prematurely. We recommend applying as soon as possible to avoid disappointment. Please click ‘apply’ or contact Simon Trebilcock for any further information

Email -  strebilcock@planet-pharma.co.uk

Telephone - +44 (0)203 928 6632.

About Planet Pharma

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its headquarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation, or age.

www.planet-pharma.com