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Quality assurance specialist

Southampton
PELHAM
Quality assurance specialist
Posted: 5 June
Offer description

Quality Assurance Specialist



Department: Quality

Location: Waterlooville, Hampshire (Hybrid)

Reports To: Head of Quality

Employment Type: Full-time



Job Summary

We are seeking a Quality Assurance Specialist to become part of an expanding Quality team to champion a culture of quality and embody the Pelham vision that ‘There’s A Better Way’. This role will be responsible for overseeing the Quality Management System, implementing and leading an internal audit process, and ensuring compliance to standardised ways of working and GMP (Good Manufacturing Practices) across the company in accordance with ISO 22716. The ideal candidate brings a strong background in quality assurance, a working knowledge of Lean tools, and the ability to collaborate cross-functionally to enhance product quality, compliance, and operational efficiency. This is a key role for someone passionate about driving quality excellence in a fast-paced, regulated manufacturing environment.



Key Responsibilities:

* Responsible for the effective management of the QMS including monitoring, SOP creation, change control evaluation and reporting on KPIs
* Maintaining the Document Management System
* Reviewing non-conformances including NCRs, CAPAs, RCA, Deviations and Complaints. Working cross-functionally to help facilitate root causes investigations and ensure timely resolution.
* Carrying out and leading internal audits with effective feedback to ensure audit readiness at all times.
* Participating in external audits by regulatory bodies, Customers and Suppliers.
* Ensuring compliance with Standards (e.g. ISO, Sedex) and Customer audit requirements.
* Working closely with other Departments (e.g. Manufacturing and Production) to ensure execution of QMS activities.
* Collaborating with all internal teams to ensure new product introductions meet quality and regulatory requirements.
* Monitoring and analysing quality metrics to identify trends, risks, and opportunities for continuous improvement.
* Driving the implementation of standardised ways of working and GMP throughout the site.
* Facilitating training programs related to quality systems, GMP, and regulatory expectations to ensure compliance and awareness across departments.
* Championing a culture of Quality and CI (Continuous Improvement) across the Company.



Experience and Qualifications:

* Proven experience in a quality assurance or compliance role preferably within the Cosmetics, Medical Device or similarly regulated industry
* Key knowledge of quality standards (e.g. ISO 22716) and GMP requirements.
* ISO Lead Auditor qualification preferred.
* Strong attention to detail and problem-solving skills
* Excellent communication and influencing abilities across different departments and levels of the company.
* Experience with RCA tools (e.g. 5 Whys, Fishbone)
* Hands-on experience with Lean tools such as 5S, Value Stream Mapping (VSM), Kaizen, and standard work.
* Passionate about quality and fostering a quality mindset in others

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