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Senior Quality Assurance Specialist

2 months ago

Borehamwood, Hertfordshire, United Kingdom EC Appointments Ltd Full time

Job Summary:

EC Appointments Ltd is seeking a highly skilled Senior Quality Assurance Associate to join their Quality Team at their Head Office. This role is ideal for a professional with QA experience within a GDP environment, seeking to develop towards the position of RP/RPi on the WDA (H).

Key Responsibilities:

  • Manage day-to-day excursions, deviations, CAPA's, change controls, and risk mitigation.
  • Develop SOPs, manage temperature excursions, and KPIs.
  • Qualify new customers and suppliers.
  • Review and make decisions on medicines licensed in the UK but manufactured in the EEA.
  • Support product approvals.
  • Plan internal and external audits.
  • Understand and support validation activities, perform risk management activities, and support route qualification activities.
  • Work closely with the RP/RPi, and work towards becoming an RP, engaging in research, learning, and training to enhance knowledge and capability.

Requirements:

  • Graduate in a pharmaceutical or related subject.
  • Quality experience within a GDP environment.
  • Proficient PC skills, maybe with a QMS system.
  • Ability to present and train within the Company.
  • Experience of performing internal and external audits.