Full-Time

Quality Officer

HeliosX

HeliosX

No salary listed

Royal Leamington Spa, UK

In Person

Category
Biology & Biotech (1)
Requirements
  • Maintain compliance with Good Distribution Practice guidelines and applicable regulatory requirements.
  • Maintain good documentation practice and data integrity principles as defined in relevant Standard Operating Procedures.
  • Ensure required training is completed and evidenced across the site.
  • Remain continuously contactable for quality matters.
Responsibilities
  • Assist in maintaining the Quality Management System.
  • Maintain Quality Management System documentation, including Standard Operating Procedures, forms, and logs.
  • Assist in ensuring periodic reviews of procedures are carried out and keep procedures and Quality Management System documentation up to date.
  • Ensure adherence to all applicable Standard Operating Procedures.
  • Ensure proper filing and retention of quality records.
  • Support deviation, complaint, Corrective and Preventive Action, and change-control processes.
  • Support product recall and mock-recall activities.
  • Assist with risk assessments and continuous-improvement initiatives.
  • Assist in reviewing relevant subcontracted activities and ensuring appropriate technical agreements are in place when outsourcing Good Distribution Practice responsibilities.
  • Assist in reviewing and maintaining bona fides for all customers and suppliers.
  • Maintain training records and coordinate Good Distribution Practice training for employees.
  • Prepare quality reports and performance metrics as required.
  • Provide support to the pharmacovigilance team by maintaining adherence to reporting and escalation processes for medical-information enquiries in line with the applicable Standard Operating Procedure.
  • Support audit readiness and address audit findings in a timely and structured manner.

Company Size

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Company Stage

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Total Funding

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Headquarters

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Founded

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