Qualified Person

By 7th February 2019
Gareth Gooley Published: 7th February 2019
Job Type
Permanent
Industry
Pharmaceuticals
Location
South East
Salary
£65000 - £78000 per annum

Description

PRIMARY RESPONSIBILITIES



This person would be primarily responsible for the certification of products. Other responsibilities include conducting audits while being able to display and communicate an in-depth knowledge of cGMP regulatory standards, licensing the unlicensed products and sterile production.



SECONDARY RESPONSIBILITIES



* Responsible 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
* Active participation in troubleshooting of GMP, GCP and GLP issues.
* Provide 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 operational
* Plan, execute and supervise the standard training programme for all new employees and maintain continuous training for all staff
* Develop training courses as a separate business unit within the department
* Maintain all professional knowledge databases
* Ad hoc projects
* Any other duties as and when required





ESSENTIAL EXPERIENCE

* Eligible to be named as a Qualified Person
* Preferable 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
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