Quality Assurance Specialist

5 days ago


Loughborough, Leicestershire, United Kingdom Kindeva Drug Delivery Company Full time
Job Title:

Kindeva Drug Delivery Company is seeking a talented Quality Assurance Specialist to join our team in supporting stability activities and ensuring Good Documentation Practices.

The successful candidate will work across cross-functional teams, representing the department as required, including external customers and regulators.

About the Role:
  • This role will support Kindeva's QC Stability Group in writing stability protocols, setting up stability studies, and writing stability reports.
Key Responsibilities:
  • Safety: Knowledge and application of current safety regulations, adhering to laboratory functions.
  • GMP: Follow 10 rules of GMP, working to appropriate laboratory systems, standards, and procedures.
  • Stability/Documentation: Interpret analytical data, write stability protocols, set up studies, and write reports to support stability testing.
  • Product, Equipment and Process Knowledge: Develop an understanding of pharmaceutical products and testing, responsible for maintenance and calibration of laboratory and stability equipment.
  • Audits: Communicate with auditors and present answers to audit questions during internal audits.
Requirements:
  • BTEC HND with 3-5 years of relevant experience.
  • 240 OU points in relevant discipline.
  • Experience with GLP, GMP, Specifications, and Test Methods.
  • 1 year of experience in testing within the Pharmaceutical Laboratory.
Benefits:
  • Life Assurance
  • Company Pensions Scheme
  • Employee Assistance Program
  • 25 days holiday per year increasing by 1 day every 5 years up to an additional 5 days.
Estimated Salary:

£45,000 - £55,000 per annum.



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