Quality Assurance Specialist

4 weeks ago

Huddersfield, Kirklees, United Kingdom Thornton & Ross Full time
About the Role

The Quality Engineer will provide front-line support to manufacturing, ensuring the execution of processes on-time, continuously improving in quality and efficiency, and performed in compliance with cGMPs, SOPs, and applicable guidelines and normatives.

Main Responsibilities
  • Provide expert support to manufacturing, working with shift teams to ensure safe, on-time, and compliant batch execution.
  • Support technology transfer projects, commercialization, and product launches of new products.
  • Execute process validations, re-validations, Annual Monitoring Batch (AMB), and short-term improvement projects, collaborating with shopfloor teams to ensure accurate execution.
  • Review and assure validation protocols and reports are technically correct.
  • Ensure protocols are executed as intended.
  • Write Manufacturing Process Transfer Documents (protocol, report).
  • Provide expertise and identify innovative validation best practices.
  • Execute process improvements and scale-up.
About You

We value diversity and uniqueness at STADA. Our values, Entrepreneurship, Integrity, Agility, and One STADA, ensure our uniqueness thrives, enabling us to care for people's health as a trusted partner. If you're keen to add value, thrive in a fast-paced environment, and have a can-do spirit, we want to hear from you.

  • Degree in Pharmacy, Pharmaceutical Technology, Chemistry, or equivalent scientific degree.
  • Combined experience in Pharmaceutical (Validation/QA) or allied industries with exposure to cGMP and GDP.
  • Strong knowledge of pharmaceutical industry, specifically in production.
  • Proficiency in English, both written and spoken.
  • In-depth knowledge of cGMPs and current validation sciences.
  • Proven process understanding (Pharma, GMP, Regulatory aspects).
What's in it for you?

We offer a range of fantastic benefits, including a competitive base salary, 25 days annual leave, generous Company Pension Scheme, Life Assurance, Annual bonus scheme, and Employee Assistance Programme.

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