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Quality Engineer at Advanced Resource Managers UK

London, Essex - England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

30 Nov, 26

Salary

45000.0

Posted On

19 Oct, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical Manufacturing

Description

Key Responsibilities:Support process and equipment validation activities, including IQ, OQ and PQ.
Lead and support risk management activities, including FMEA reviews and updates.
Ensure changes are effectively managed through established change control processes.
Drive quality improvements through data analysis and trend monitoring.
Support new product and process introduction projects.
Participate in internal, supplier and external audits.
Lead and support CAPA investigations, root cause analysis and corrective actions.
Review and approve documentation within the electronic Quality Management System (eQMS).

Requirements:A minimum of 3 years' Quality Assurance experience within a regulated industry
Working kndowledge of GMP, ISO 13485 and/or FDA Quality System Regulations
Experience writing, executing, reviewing or approving validation protocols and reports
Knowledge of risk management methodologies, including FMEA and ISO 14971 or similar frameworks
Experience supporting CAPA, change management and quality system activities
Strong communication, organisational and stakeholder management skills
Degree qualified, or equivalent experience gained within a similar regulated environment

Responsibilities