Quality Management Associate
- Full-time
- Department: PV QM
Company Description
PrimeVigilance, an Ergomed brand , was established to provide specialised pharmacovigilance services to pharmaceutical and biotechnology companies. These services cover the science and activities relating to the detection, assessment, understanding and prevention of adverse effects.
Ergomed Plc is a public company on the London stock exchange with its HQ in Guildford, UK. The company boasted 40% growth in its revenues in its last report. This success is due to the hard work of our highly skilled employees and our subsequent reputation for excellence with our clients.
Job Description
The Quality Management Associate, QEs and CAPA and is supporting administration, tracking and ensuring that Quality Events (QEs) and Corrective and Preventative Actions (CAPAs) are completed in accurate and timely manner and are managed in compliance with global regulations, legislation and PrimeVigilance requirements.
ROLE AND RESPONSIBILITIES
• Support PrimeVigilance Quality Team and Quality Manager, QEs and CAPA in recording and tracking deviations, non- conformities, issues - and CAPA plans.
• Support the Quality Manager, QE and CAPA team for gathering information of deviations data across the company
• Assisting Quality Manager, QE and CAPA Team in developing and managing project-specific documentation, deviation and CAPAs trackers and in managing relevant project- specific training
• Supporting and assisting Subject Matter Experts to conduct root cause analysis or QEs and CAPAs
• Assist QE and CAPA, Quality manager in audits and inspections to by providing and gathering information of deviations, documentation on relevant projects.
• Support administrating and tracking deviations and reviewing CAPAs process
Qualifications
Educated to degree standard or appropriate equivalent work experience
Previous experience in a Quality of Compliance-related role in any environment is desirable but not required
Prior experience of using an Electronic Quality Management System desirable but not required
English - advanced (spoken, written)
Excellent communication and facilitation skills within a global organization
Excellent approach to workload management and ability to deliver results in tight timelines
Flexible approach to work and positive response to process change where necessary
Good attention to detail
Proactive and self-motivated
Good organization skills and ability to multitask
Additional Information
All your information will be kept confidential according to EEO guidelines.
Our Offer:
- Work within a successful, highly – qualified and dynamic team
- Professional training and career development in a fast-growing healthcare company