Quality Assurance Specialist

6 days ago

Huddersfield, Kirklees, United Kingdom Thornton & Ross Full time

About the Role:

The Quality Assurance Specialist will provide front-line support for all process-specific issues to production within one or more production steps, ensuring execution of processes on-time, continuously improving in quality and efficiency, performed in compliance to cGMPs, SOPs and applicable guidelines and normatives.

Main responsibilities include but are not limited to:

  • Providing front-line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
  • Supporting the completion of technology transfer projects, commercialization, and product launch of new products.
  • Executing process validations, re-validations, Annual Monitoring Batch (AMB) and short-term improvement projects, liaising with all the relevant parties at shopfloor to ensure accurate execution.
  • Reviewing and assuring that validation protocols and reports are technically correct.
  • Ensuring protocols are executed as intended.
  • Writing Manufacturing Process Transfer Documents (protocol, report).
  • Providing expertise and identifying and implementing innovative validation best practices.
  • Executing process improvements and scale-up.

About You:

At Thornton & Ross, we value diversity and uniqueness. Our values, Entrepreneurship, Integrity, Agility and One STADA, ensure our uniqueness thrives, enabling us to care for people's health as a trusted partner. Empower your Uniqueness, bring your whole self to STADA. If you're keen to add value and see results, thrive in a busy fast-paced environment and have the can-do spirit that's spearheading our success, bring those qualities, with the following:

  • Degree in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific degree or
  • 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?

Rewarding our employees is important to us, which is why we offer a range of fantastic benefits, such as:

  • 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.

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