Qualified Person - Middlesex
Jason Johal at CK Science is currently recruiting for a Qualified Person to join a privately owned pharmaceutical company which manufactures and distributes pharmaceutical and healthcare products to the UK market. They offer a wide range of products and services which include specials, generic drugs, branded medicines, parallel trade and over the counter (OTC) medicines. With over 1000 employees and still growing they believe that investing in their people has been the key to their success.
The QP will 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, supporting the licensing new application for QP declaration and others. This role is offered on a full time permanent basis.
Your main responsibilities in this role will be to:
- Be responsible for the review and approval of Standard Operating Procedures, review and approval of study protocols, and auditing (internal and external).
- Audit for GMP, GCP GDP and GLP purposes, using your experience of Quality Management Systems covering all aspects of Licensed Manufacturing sites
- Actively participate in troubleshooting of GMP, GCP and GLP issues.
- Provide input into the Regulatory strategy for the development of pharmaceutical products in the UK
- License the unlicensed medicines for the UK market
- Liaise with the Regulatory Authority/MHRA contact for all pharma products sold in UK
- Work cross functionally with Pharmacovigilance, Regulatory Affairs, Clinical Research
- Be involved in all aspects of the sterile production including design, installation and operation
- 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
You are required to have the following qualifications, skills and 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)
- PLPI Assembly operation
- Practical experience of auditing for GMP, GCP GDP and GLP purposes
- Experience of Quality Management Systems
- Experience of Parallel Imports
If you are successful you will be joining a pharmaceutical company that has continuously grown in a systematic and consistent manner expanding its product line by acquiring licenses rapidly. Currently, they have more than 2000 licenses with several licenses in the pipeline enabling them to provide more options to their customer base which includes 50% of the market share of the estimated 6000 UK independent pharmacists.
For more information or to apply for this Qualified Person position please contact Jason on +44 (0)1438 723 500 or email email@example.com. Alternatively, please click on the link below to apply online now.
CK Science is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST33617 in all correspondence.