Job Reference: J5632917
Updated On: 11/02/2020
Status: Open to Applications
Back to results
Role OverviewWe are currently recruiting for a Qualified Person / QP on a contract basis to join a leading Pharmaceutical company in the South East.
The role of the Qualified Person is integral to the success of the Quality Department in delivering expert advice and ensuring release of clinical/commercial supplies, in line with customer expectations and regulatory demands. The Qualified Person will ensure that finished products are not released until their quality has been judged to be satisfactory as measured against specifications and regulatory requirements.
Key Duties and ResponsibilitiesThe duties of the Qualified Person / QP are broad and a detailed job description is available on request. An example of such duties include:
1) Act as a Qualified Person under EU Directive 2001/20/EC for the release of batches imported to or processed, fulfilling the requirements specified in article 13.3 and undertaking the duties outlined in Annex 13.
2) Determine the requirements for, and level of release necessary for materials handled, including the release of just-in-time labelled material for despatch.
3) Evaluate study supply chains and assess, as applicable, each site involved to ascertain compliance with standards at least equivalent to EU GMP. Audit manufacturing and testing sites as well as compiling audit reports to a high standard in accordance with the relevant procedure.
Role RequirementsThe successful Qualified Person / QP will need to demonstrate the following in their profile to be considered:
1) Degree in a relevant scientific discipline and be eligible to be appointed as Qualified Person under the permanent provisions to our client's license.
2) Experience in undertaking the routine duties of a Qualified Person as well as experience in auditing suppliers, API facilities, drug product manufacturing or testing sites and exposure to more than one dosage form (steriles/biologics would be advantageous)
Other jobs with similar skills
United Kingdom | Experience Dependant
We are currently recruiting for a Qualified Person / QP on a contract basis to join a leading Pharmaceutical company in the South East. The role of the Qualified Person is integral to the success o...Science
View & Apply
QA (Quality Assurance) Associate
Berkshire, Berkshire | Experience Dependant
To ensure that Quality is maintained at an appropriate level meeting, customer and regulatory expectations. This will be achieved by assessing compliance to site PQS and principles of GMP auditing doc...Science
View & Apply