Drug Product Development Lead

7 hours ago


Hoddesdon, Hertfordshire, United Kingdom Pharmaron Full time

About the Role:

We are seeking a highly skilled Senior Quality Assurance Advisor to join our Drug Product Development team in Hoddesdon, UK.

This role is responsible for ensuring the day-to-day operation of the Quality Management System to support GMP manufacture of API and Drug Product.

The successful candidate will have experience in a Quality Assurance role within the Pharmaceutical industry, with a strong understanding of quality management systems and regulations.

The salary for this position is estimated to be around £60,000 - £80,000 per annum, depending on experience.

Key Responsibilities:

  • Maintaining the Quality Management System to ensure compliance with regulatory requirements
  • Conducting internal audits and assisting with external audits by clients and regulatory authorities
  • Generating metrics and performing periodic reviews of Quality Systems
  • SUPPORTING THE VENDOR MANAGEMENT PROCESS, INCLUDING PERFORMING VENDOR QUALIFICATIONS, AUDITS AND REVIEWS
  • Investigating deviations, quality issues and trends and contributing to continuous improvement
  • Providing QA support on change controls and OOS
  • Writing Quality Technical Agreements
  • SUPPORT QUALIFICATION/VALIDATION ACTIVITIES
  • Providing Quality representation and input at project and planning meetings

Requirements:

  • Degree level qualification in Chemistry or related scientific subject
  • Demonstrable experience in a Quality Assurance role within the Pharmaceutical industry
  • Strong interpersonal and relationship-building skills with the ability to influence and encourage a quality mindset
  • Excellent planning and organization skills with the ability to multi-task, manage time and accept changing priorities
  • IT Skills with a good working knowledge of MS Office


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