Job description

Requirements

  • Entry level
  • No Education
  • Salary £65,000.00 - £80,000.00 gross per year
  • SURREY SURREY

Description

A great opportunity has arisen for an energetic, flexible, innovative, and driven individual with several years’ experience and responsibility for Quality Management Systems, to ensure compliance with requirements of GMP procedures.

Principle role:

Maintaining the Company’s Quality Management System and monitoring production activities to ensure that they comply with documented procedures.

The successful candidate will be qualified to BSc or PhD in Chemistry, Biochemistry or relevant scientific discipline and have worked as a Qualified Person for medicinal products (as defined Directive 2001/83/EC). The ideal candidate should have at least 5-10 years’ experience in a GMP, QA role within the pharmaceutical industry and experience of managing quality systems.

Key Responsibilities:


- Review of batch and analytical records from production and QC teams
- Management of QMS and monitoring compliance with GMP and quality improvements
- Review and approval of deviations from laboratory investigations in compliance with GMP and AMR procedures• Also, ensuring that testing is carried out according to Pharmacopoeia specifications.
- Review and approval of documentation including Change Control, Deviation Reports and SOPs
- Maintaining and updating document control lists
- Review and maintenance of the company’s Quality Management System,
- Support site validation activities, ensuring that regulatory requirements are met.
- Generate Validation Protocols, reports and carry out of equipment validation as required
- Review and Approve validation paperwork generated by others
- Investigation of complaints and to ensure that necessary corrective actions are carried out
- Review and approval of new suppliers and products
- Carrying out and participating in risk assessments for new and existing products

The successful candidate will have the following qualities:


- Excellent attention to detail and ability to follow processes
- Strong written and verbal communication skills
- Ability to work independently as well as part of a small team
- Experience of Quality Assurance in the medical device, pharmaceutical or biotech industries would be highly desirable

Requirements: Registered QP, Min BSc in Science discipline, Experience in the pharmaceutical industry, Extensive knowledge of EU/MHRA and FDA regulatory environments, Knowledge/experience in working within sterile manufacturing environments.

We can only accept applicants who are eligible to live and work in the UK without restrictions


- GMP
- Quality Management
- Pharmaceutical Industry
- Qualified Person - pharmaceutical
- EU/MHRA and FDA regulatory

  • ms project