Regulatory Quality Specialist

4 days ago

Birkirkara, Birkirkara, Malta Quad Consultancy Full time
About the Role

We are seeking a highly skilled Regulatory Quality Specialist to join our team at Quad Consultancy.

Job Description

The successful candidate will be responsible for maintaining quality oversight of SOPs, developing procedures and controls in support of the Quality Management System, and providing ongoing support to the CMC function to ensure delivery of GMP requirements.

Main Responsibilities:
  • Review data for reports, investigations, KPIs, and other quality indicating metrics and trend analysis
  • Maintain stability programmes on all protocols, reports, and data is available
  • Forward manufacturing batch records and release documents to stakeholders
  • Manage complaints and deviation investigations related to manufacturing activities
  • Track associated Corrective Actions/Preventive Actions
Requirements:
  • Minimum of 5 years experience with GMP Operational Quality Systems for Commercial Drug Product in a pharmaceutical or other life science organisation
  • Experience in utilising quality System processes (such as Audit, Deviations, CAPA, Risk assessments & Change Control)
  • Strong written and verbal communication skills
  • Ability to work in a fast-paced environment and under pressure
  • Eligibility to work in the EU is a must
What We Offer:

We offer a competitive salary of approximately €45,000 per year, plus benefits, including opportunities for professional growth and development.

About Us:

Quad Consultancy is a leading consulting firm specialising in pharmaceutical and life sciences industries.

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