Qualified Person – Pharmaceuticals – South East – All Dosage Forms

A growing pharmaceutical company who has gone form a turnover of £15 million to over £300 million in 4 years are looking to support their rapid expansion with the hiring of a Qualified Person (QP) to support their South East facility. With several international sites they have a huge portfolio of products and they are looking to increase this within their new manufacturing facility.

Following the companies successful growth they require a QP to take responsibility for the certification of products, conducting audits, displaying an in-depth knowledge of cGMP regulatory standards and supporting set up of a new manufacturing facility.

Key Responsibilities Include:

Responsible for review/ approval of Standard Operating Procedures, review and approval of study protocols, and auditing (internal and external).
Auditing for GMP, GCP GDP and GLP purposes
Management of Quality Management Systems covering all aspects of Licensed Manufacturing sites
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 and 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 departmentEssential Experience

Eligible to be named as a Qualified Person- Essential
Experience in the licensed manufacture of the oral solids, oral liquids, sterile’s, creams, liquids and ointments (preferred- non essential)
Experience in PLPI Assembly operation
Practical experience of auditing for GMP, GCP GDP and GLP purposes
Experience of Quality Management SystemsThis is a fantastic opportunity for any QP looking to expand their experience in a wide range of dosage forms across manufacturing and parallel import due to the organisations huge product portfolio. Aside from this- you will be directly involved in projects such as the set up and design of a new state of the art manufacturing facility- experience that is invaluable on any QPs CV.

The client are willing to offer a very competitive salary and benefits package.