Location

Worthing
Discipline:

Regulatory Affairs
Job type:

Permanent Full Time
Job ref:

010127
We are seeking an experienced and motivated professional to manage the Quality and Regulatory Supply Chain activities for our medicinal products portfolio across the EU and UK markets. This role is pivotal in ensuring compliance with key regulatory frameworks, including EU GDP Guidelines (2013/C 343/01), MHRA guidance, and Directive 2001/83/EC.
You will oversee contract manufacturing and logistics operations, collaborate with regulatory service providers to ensure product dossiers are maintained, and ensure products are manufactured in line with the respective manufacturing authorizations.

WHAT EXPERIENCE & SKILLS DO YOU NEED:

• BS and/or MS degree in science and 5 years of experience in Quality Assurance or 10 years work experience in the related area
• Knowledge of the principles and practices of computer applications including word processing, spreadsheet, database management, and presentation software and internet search engines
• Excellent written and verbal skills required
• Must display strong analytical and problem-solving skills
• Attention to detail is extremely important, as is the ability to adapt quickly to changing regulations
• Experience within the Ophthalmology sector
• Qualified Auditor
• Acting as deputy RP/RPi under a WDA(H)

• Conduct onboarding, re-qualification, and ongoing monitoring of third-party organizations. This includes planning and reviewing desktop audits, performing on-site audits, conducting bona fide checks, preparing QTA’s and ensuring continuous compliance.
• Perform and document regular customer qualification checks in line with internal procedures and regulatory expectations.
• Log and risk-assess internal and external change controls.
• Manage changes through to completion within defined timelines, and provide regular updates to your line manager.
• Log, assess, and manage product complaints, escalating to the pharmacovigilance partner and line manager when there is potential for recall scenarios.
• Ensure timely resolution in compliance with regulatory standards.
• Log and risk-assess internal and third-party non-conformances.
• For internal issues, lead investigations, perform root cause analysis, and implement effective CAPAs.
• Monitor progress and report status updates to the line manager.
• Compile and analyse monthly KPIs related to CAPAs, change controls, and non-conformances.
• Identify adverse trends and develop appropriate corrective measures.
• Prepare and contribute to the annual Quality Management Review in alignment with the standard reporting template.
• Develop, revise, and review Standard Operating Procedures (SOPs) and Work Instructions (WIs) to ensure they remain current and compliant.
• Actively participate in internal and external stakeholder meetings, contributing quality and compliance insights.
• Track and review product stability and PQR data, escalating issues to your line manager as needed.
• Support the internal self-inspection program by acting as an internal auditor.
• Prepare audit reports and manage associated CAPAs.
• Serve as a scribe during external audits of the Global Rayner Surgical Pharma QMS and assist in audit readiness and follow-up actions.
• Adhere to the Global Rayner Surgical Pharma Quality Management System (QMS) and proactively identify opportunities for continuous improvement.