We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, PharmaLex is your career opportunity. PharmaLex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.


Senior Specialist, Quality Assurance

This is a newly created part time position, working 22.5 hours a week.  There is also an opportunity to consider full-time candidates with some additional tasks for the global Quality Assurance (QA) team, as outlined at the bottom of this section. 

Your Job

The part-time position is responsible for the following tasks in the UK:

  • Contributing to the maintenance of the overall Quality compliance of PharmaLex UK
  • Set up and monitor processes that ensure the organisations Quality Management System (QMS) conforms to customer, internal, ISO 9001 and regulatory/legal requirements
  • Achieve Quality Assurance Operation Objectives by contributing information, identifying critical control points and preventative measures and analysis to strategic plans and reviews
  • Set up and maintain controls and documentation procedures for functions of Quality Assurance
  • Review of internal processes, especially those that affect the quality of the organisation’s products
  • To establish the procedures using controlled documents such as SOPs, WIs and WPs
  • Review of the training records for all employees
  • Report to senior management on the performance of the QMS (e.g. results of quality audits, corrective actions, deviations and complaints), including the need for improvement
  • Coordinate periodic management review meetings
  • Responsible for handling external audits as required
  • To facilitate internal audits and vendor qualifications
There is an option to add some additional tasks, working in the global Quality Assurance team (for the remaining 15 hours a week) if a full-time position is desired. The Main tasks for the global part of the role are as follows:
  • Manage and support Client/Health authority Audits and Inspections (Organising / Backoffice)
  • Provide support and knowledge on QA topics to internal stakeholders, especially those needed for representation of QA towards clients and authorities in audits: Deviation and CAPA management, KPIs, Global and local SOPs, Trainings
  • Support eQMS (document up/download, training matrix, CAPA management)
  • Support and develop VDC-specific-SOP writing, incl. revision
  • Manage and optimise QA processes in collaboration with global QA

Your Profile

  • Graduate/post-graduate/doctorate degree in life sciences/pharmacy/medical sciences or equivalent degrees
  • Able to demonstrate  experience relevant to the role 
  • Comprehension of Quality Assurance
  • Knowledge of ISO requirements
  • Ability to analyse and solve problems and to develop possible solutions
  • Ability to represent the company towards external clients
  • Excellent attention to detail
  • Autonomous, concentrated and able to produce a high standard of work
  • Resilient and flexible
  • Excellent written and verbal English communication skills
  • Ability to work in a team
  • Experience with electronic Quality Management Systems would be advantageous

We offer

  • Competitive salary and benefits package
  • 25 days holiday plus bank holidays (increasing to 27 after qualifying service)
  • 8% employer pension contribution
  • An opportunity to work within an organisation with a positive work/life balance environment
  • Continuous development opportunities through knowledge and experience as well as training

If you are interested in joining our PharmaLex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

For further information please don’t hesitate to contact us:

Helen Pietropaolo
Manager, Human Resources UK


Agencies only by prior agreement for the specific job opportunity.