2 days left
- Experience Level
- Experienced (non-manager)
QUALIFIED PERSON (QP)
Salary: Excellent/Dependent on experience and full benefits package
Our client, a leading supplier of pharmaceuticals to the pharmacy sector and with a genuine growth strategy including new manufacturing facilities is currently looking to strengthen their Quality function with the recruitment of a Qualified Person (UK/EU) for their London headquarters.
As the Qualified Person (QP), responsibilities will include (but not be limited to):
• Responsiblility for the certification of all products.
• Conducting audits and communicating an extensive knowledge of cGMP regulatory standards, licensing the unlicensed products and sterile production.
• Responsibility for the review and approval of Standard Operating Procedures, review and approval of study protocols, and auditing (internal and external).
• Auditing for GMP, GCP, GDP and GLP purposes, experience of Quality Management Systems covering all aspects of Licensed Manufacturing sites
• Actively participating in troubleshooting of GMP, GCP and GLP issues.
• Providing input into the Regulatory strategy for the development of pharmaceutical products in the UK
• Licensing the unlicensed medicines for the UK market
• Liaising with the Regulatory Authority/MHRA contact for all pharma products sold in UK
• Working cross functionally with Pharmacovigilance, Regulatory Affairs, Clinical Research
• Being involved in all aspects of the sterile production including design, installation and operations
• Taking responsibility for the execution and supervision of the standard training programme for all new employees continuous training for all staff
• Various Ad hoc projects
The successful candidate will possess:
• Eligiblility to be named as a Qualified Person (Our client is willing to consider applications from EU Qualified Persons who are keen to relocate to the UK
• Preferably Experience in the licensed manufacture of the following:
Oral solid dosage
Oral liquid dosage
Sterile dosage form
Semi-solid / topical products (Creams, liquids and ointments)
• Parallel import operations
• Practical experience of auditing for GMP, GCP, GDP and GLP purposes
• Experience of Quality Management Systems
This role represents an outstanding opportunity for a talented Qualified Person to undertake a varied role in a growing business.
If you are interested in this opportunity Please call Jim Maddison at Scientific Professionals on +44 (0) 207 822 1710 or send an updated version of your CV via email to email@example.com
Not quite the right role for you? We do operate a generous bonus referral scheme should we go on to place anyone that you recommend to us so please feel free to pass these details forward.
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