Quality Specialist

R&D Partners; Slough; On-site; GBP 42,000 - 56,000; Full time

Job summary

R&D Partners is seeking a Quality Specialist to join a leading pharmaceutical company in Slough, UK, on a 12-month contract. The role focuses on supporting the execution and maintenance of the Quality Management System (QMS) while ensuring GMP and GDP compliance.

Responsibilities include managing deviations, change controls, complaints, CAPAs, and training. You will work with cross-functional teams and contribute to recalls, stability programs, and regulatory inspections as needed.

Qualifications

• Bachelor's degree in Life Sciences (e.g., Biology, Chemistry, Pharmacy).
• Ideally 5+ years in pharmaceutical quality roles; candidates with strong qualifications considered.
• Experience in GDP environment is advantageous.

Responsibilities

• Support the implementation and maintenance of the Quality Management System (QMS).
• Manage records such as deviations, change controls, and complaints.
• Collaborate with Affiliate Management, Market Quality, Global Quality, Supply Chain, Pharmacovigilance and Regulatory teams.
• Identify quality issues and drive CAPAs to closure within timelines.
• Track and trend quality system data and KPIs.
• Generate Annual Product Quality Reviews per procedures and schedules.
• Maintain training curricula and matrices for the Quality Department.
• Manage product traceability and recalls as required.
• Coordinate stability program for local products and compassionate use supply.
• Support affiliate self-inspections and management reviews of quality systems.
• Prepare for regulatory inspections and address deficiencies with CAPAs.
• Oversee local vendor quality compliance and periodic assessments.

Skills

Pharma QA

GxP compliance

GDP/GMP

Documentation & Records

CAPA management

Stakeholder collaboration

Attention to detail

Independent & collaborative 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.

For more information, please contact Mandi Cakwe.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.r-dpartners.com/privacy-policy/