Pharmaceutical Quality Assurance Lead

2 weeks ago

Alnwick, Northumberland, United Kingdom Quotient Sciences Limited Full time

We are seeking a highly skilled Pharmaceutical Quality Assurance Lead to join our team at Quotient Sciences Limited. As a key member of our Compliance and Quality Assurance team, you will be responsible for ensuring that our GMP activities are conducted in accordance with current regulations, standards, company policies and procedures.

Main Responsibilities
  • To own the development and delivery of GMP training programs, including but not limited to:
    • GMP Basic principles
    • Initial GMP Training
    • Refresher GMP Training
    • Specialised GMP Training (in conjunction with functional experts)
  • To track and trend quality metrics and work with the Senior Director, Compliance and Operations Leadership Team to address areas of poor performance.
  • To own and improve GMP document control processes.
  • To oversee various QMS processes including CAPAs, risk management, change control, internal/external auditing, supplier management, etc.
  • To assist the QA team with the planning, conduct, reporting and follow up of internal, client and supplier audits.
  • To provide QA oversight on continuous improvement initiatives and work collaboratively to promote continuous improvement of the QMS.
  • Involvement in regulatory inspections as required.
Requirements
  • Minimum 5 years' experience in a GMP QA role within the pharmaceutical or related industries.
  • Hands-on experience of overseeing Quality Management System compliance and proven track record of delivering quality systems improvements.
  • Leadership and Management experience preferred.

Quotient Sciences Limited is an equal opportunities employer and welcomes applications from all qualified candidates. We are committed to creating a diverse and inclusive workplace culture.

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