Audit and Quality Assurance Officer

3 days ago


Cramlington, Northumberland, United Kingdom Sterling Pharma Solutions Full time

Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Sterling Pharma Solutions. As a key member of our Quality team, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.

Key Responsibilities

  • Perform batch sentencing activities on a named set of products and all quality assurance activities, including reviews and approvals, in accordance with current Good Manufacturing Practice (cGMP) and regulatory standards.
  • Collaborate with internal stakeholders to address quality-related matters and ensure effective communication.
  • Conduct visual inspections of plant equipment and pre-start up audits on plant.
  • Review and approve Change Control and temporary instructions using Master Control.
  • Complete deviation investigations using Master Control and assist with data gathering for stakeholders within the business.

Requirements

  • Previous pharmaceutical experience is essential, ideally within Active Pharmaceutical Ingredient (API) manufacturing.
  • Knowledge of quality assurance, laboratory practices, and production is necessary.
  • Strong analytical and problem-solving skills, with the ability to work independently and as part of a team.

What We Offer

  • A competitive compensation and benefits package, including bonus, pension scheme, private healthcare, and more.
  • Opportunities for training and further career development.
  • A dynamic and supportive work environment, with a focus on employee wellbeing and work-life balance.

About Us

Sterling Pharma Solutions is a global pharmaceutical Contract Development and Manufacturing Organisation (CDMO) with over 50 years of experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). We are a trusted partner to some of the world's most innovative biotechs and leading pharmaceutical companies, and are widely recognised for our expertise in complex and hazardous chemistry.



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