Quality Specialist - Operations

Healthcare - Basildon, Essex

Ref: 11Wednesday 14 September 2022

£40,000 - £50,000 + Benefits

Are you a Quality Specialist with pharmaceutical experience? Could you provide quality support to Quality Systems, Operational Quality and Technical Quality teams as required? Then this role could be for you.

Our client, a fast-growing global pharmaceutical company with offices in the UK, and globally is currently looking for a Quality Specialist who has knowledge and experience of

  • Performing distributor audits and progress QTAs with distributors
  • Providing quality operations support to approved vendors and ensure that any risks are communicated effectively.
  • Reviewing pharmaceutical product batch files for timely release by responsible person (RP),
  • Being the responsible person for Importation (RPi), or certification by Qualified Person (QP).
  • Providing QA support to the business during root cause analysis investigation
  • Raising third party notification, CAPA, GDP issues, Deviation and Change Control.
  • Supporting activities required to effectively maintain the company Pharmaceutical Quality System
  • Monitoring alerts for potential overdue for Complaints, CAPA, GDP issues, Deviation and Change Control.

To be considered for this quality systems role, you will need to have a degree in Pharmaceutical Science or equivalent and you must also have good working knowledge of Current Manufacturing Practices, Standard Operating Procedures, EU GMDP guidelines, regulations and ICH Guidelines. It would also be very beneficial for you to have the following skills and knowledge which include

  • Proven experience of manufacturing, API, solid dosage forms, liquids, creams and sterile products
  • Previous of facilitating OOS and Root Cause Analysis
  • Previous experience of working in a Quality Department of a pharmaceutical company in a role with increasing responsibility.
  • Any experience of Previous experience of routinely preparing Quality & Technical Agreement.
  • Previous Auditing experience would also be very much welcomed

You must be commutable to the client’s Basildon HQ, as the team are working in the office a couple of times per week with the rest of the working week spent at home.

This quality specialist the role comes with an excellent salary, discretionary bonus, , 25 days holiday, single private Healthcare cover and standard pension.