Quality Specialist

R Dpartners; Slough; On-site; GBP 42,000 - 65,000; Full time

Job summary

R&D Partners in Slough invites a Quality Specialist to join a leading pharmaceutical company on a 12-month contract. The role focuses on supporting the Quality Management System and ensuring GMP/GDP compliance across the EU.

You will work with Affiliate Management, Market Quality, and Regulatory teams to drive CAPAs, deviations, change controls, and product release readiness, while maintaining training matrices and supporting regulatory inspections.

Qualifications

• Bachelor's degree in Life Sciences required.
• Minimum 5 years in pharmaceutical quality role preferred; strong qualifications considered with less experience.
• Experience in GDP environment is advantageous.

Responsibilities

• Support the Quality Management System (QMS) maintenance and deviations/changes/complaints in line with procedures.
• Collaborate with Affiliate Management, Market Quality, Global Quality, Supply Chain, Pharmacovigilance, and Regulatory teams to ensure timely GxP operations.
• Provide SME input and represent Quality in meetings, projects, and initiatives.
• Identify quality issues and drive corrective/preventive actions (CAPAs).
• Track and trend quality system data and KPIs; generate Annual Product Quality Reviews.
• Maintain training curricula and matrices for the Quality Department.
• Manage product traceability, including recalls or suspected falsified products.
• Coordinate the local stability program and support compassionate use supply.
• Contribute to affiliate self-inspections and management reviews of quality systems.
• Prepare for regulatory inspections and address deficiencies through CAPAs.

Skills

Quality assurance

GxP

CAPA management

Documentation

Stakeholder collaboration

Regulatory inspections

Attention to detail

Communication

Independent & team work

Education

Bachelor's degree in Life Sciences

Job description

Join a pioneering healthcare organisation and lead the medical strategy behind innovative diagnostic solutions across the EU.

R&D Partners is seeking a Quality Specialist to join a leading pharmaceutical company in Slough, UK, on a 12-month contract. This role focuses on supporting the execution and maintenance of the Quality Management System (QMS) while ensuring compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). The ideal candidate will have a strong background in pharmaceutical quality assurance and a proactive approach to identifying and resolving quality issues.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Support the implementation and maintenance of the Quality Management System, including managing records such as deviations, change controls, and complaints in compliance with internal procedures.
• Collaborate with stakeholders across Affiliate Management, Market Quality, Global Quality, Supply Chain, Pharmacovigilance, and Regulatory teams to ensure timely delivery of GxP operations.
• Provide subject matter expertise and represent the department in meetings, projects, and improvement initiatives.
• Identify quality issues, highlight improvement opportunities, and facilitate the development of solutions.
• Ensure Corrective and Preventative Actions (CAPAs) are raised, tracked, and closed within target timelines.
• Track and trend quality system data and key performance indicators.
• Generate Annual Product Quality Reviews in line with company procedures and schedules.
• Maintain training curricula and matrices for the Quality Department, ensuring staff compliance with the quality system.
• Manage product traceability, including handling returned, rejected, recalled, or falsified products, and participate in local and global recall activities as required.
• Coordinate the stability program for local products and support compassionate use supply.
• Contribute to the affiliate annual self-inspection program and periodic management reviews of quality systems.
• Prepare for regulatory inspections and address deficiencies identified through audits by implementing corrective and preventive actions.
• Oversee local vendor quality compliance, including qualification, quality agreements, monitoring, and periodic assessments.

Key Skills and Requirements:

• Education: Bachelor’s degree in Life Sciences (e.g., Biology, Chemistry, Pharmacy).
• Experience: Ideally, a minimum of five years in a pharmaceutical quality role; candidates with less experience but strong qualifications will also be considered.
• Experience working in a GDP environment is advantageous.
• Strong organizational skills with the ability to manage assignments through to completion.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively as part of a team.
• High attention to detail and accuracy.
• Proven ability to manage complex and challenging situations.