Senior Quality Manager/Trainee QP

Role: Senior Quality Manager/Trainee QP

Location: Slough

Contract Length: Permanent

Our client is a respected, global leader in Clinical Supply Trials and are experiencing a period of unparalleled growth. They are growing not just in the UK but also across Europe and the USA. This is an opportunity for an ambitious, skilled professional to make a real change in an exciting environment.

As Senior Quality Manager you will ensure compliance with MHRA guidelines concerning medicines & Home Office guidelines for Controlled Drugs.

To add to this our client will support you in the final stages of your QP training and provide you with the tools to elevate your career into senior management.  This is a rare opportunity not to be missed!

What you will do…

• Work to ensure goods are of a high standard
• Implement and maintain an efficient eQMS
• Lead QMR meetings
• Work closely with Germany and US teams
• Make sure conditions of the wholesale dealer’s license are met, and the guidelines of Good Distribution Practice are complied with
• Review SOP’s
• Liaise with the MHRA and Home office as and when necessary.
• Work alongside QP for goods arriving from outside the EU
• Provide training for employees.
• Ensure that the activities of the company are properly reflected in the Wholesale Dealer’s Licence and the provisions of the Wholesale Dealer’s Licence are observed
• Oversee audit of the quality system and to carry out independent audits
• Ensure appropriate standards of GDP
• Ensure Technical Agreements are in place
• Carry out risk assessments
• Carry out validation exercises on new processes, equipment and changes.

What you will need to have…

• Knowledge of The Medicines Act 1968
• GMP experience
• Good Understanding of the Wholesale Dealer’s Licence
• Knowledge of, The Human Medicines Regulations (UK SI 2012 1916)
• Understanding of Directive 2001/83/EC as amended, of the Community Code relating to medicinal products for human use
• Understanding of the new Guidelines for Good Distribution Practice of medicinal products for human use
• Knowledge of Commission guidelines for GDP of medicinal products for human use (2013/C 68/01)

What you need to do to apply…

For more information reach out to Alice Bryce, Quality and Validation Recruitment Specialist at Umbilical Life… You can find Alice on LinkedIn or send an email to alice.bryce@umbilical-life.com