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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, working with shift teams to ensure the execution of processes on-time, continuously improving in quality and efficiency, performed in compliance with cGMPs, SOPs, and applicable guidelines and normatives.

Main Responsibilities
  • Provide expert support to manufacturing, focusing on manufacturing each batch safely, on time, in compliance with batch instructions and quality requirements.
  • Support the completion of technology transfer projects, commercialization, and product launch of new products.
  • Execute process validations, re-validations, Annual Monitoring Batch (AMB), and short-term improvement projects, liaising with relevant parties to ensure accurate execution.
  • Review and assure that 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 and see results, thrive in a busy 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 (i.e., 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:

  • Competitive base salary.
  • 25 days annual leave (plus bank holidays) and the opportunity to buy an additional 5 days leave.
  • Generous Company Pension Scheme.
  • Life Assurance.
  • Annual bonus scheme.
  • Employee Assistance Programme.