Sharp is a global leader in clinical supply chain services and pharmaceutical packaging. For more than 65 years, we’ve provided solutions to pharma and biotech clients from phase I trials through to commercial launch and lifecycle management. With facilities in the United States, United Kingdom, Belgium and the Netherlands and 30+ clinical depots globally, covering every region of the world, we are engineered to deliver.
We are pleased to be hiring a Quality Coordinator at our UK site, based onsite in Rhymney, Wales.
The Quality Coordinator supports the effective operation of the site Quality Management System by providing a combination of hands-on quality coordination and routine administrative support. The role is responsible for reviewing and coordinating GMP documentation, supporting pre-production and post-production documentation checks, material introduction activities, and assisting with deviations, CAPA, change controls, validation documentation, data trending, and audit readiness. The post holder also maintains trackers, filing systems, scanning, archiving, and other administrative tasks required to keep quality processes controlled, compliant, and efficient.
Duties and Responsibilities:
- Carry out pre-production and post-production documentation reviews to confirm records are complete, accurate, and compliant before progression to the next stage.
- Review batch documentation, supporting records, and reconciliation details to identify errors, gaps, or inconsistencies requiring correction, follow-up, or escalation.
- Perform material introduction documentation reviews and approvals to verify accuracy and are complete and in line with site procedures.
- Support the coordination and progression of deviations, investigations, CAPA, change controls, complaints, and other quality system records to help ensure timely closure and robust documentation.
- Monitor open actions, workflow queues, and due dates within assigned quality processes, following up with stakeholders to maintain progress against agreed timelines.
- Escalate documentation issues, overdue actions, or potential compliance risks to the appropriate Quality personnel to support timely resolution and reduce risk to the business.
- Work closely with Production, QC, Engineering, Supply Chain, and Quality colleagues to resolve documentation issues, obtain missing information, and maintain GMP compliance across routine operations.
- Support validation activities through the collation, checking, and organisation of validation data and associated records to support protocol execution, reporting, and record completion.
- Support the compilation, analysis, and trending quality and operational data to support reporting, management review, continuous improvement, and identification of recurring issues.
- Support the preparation of quality metrics, dashboards, logs, and trackers to provide visibility of performance, compliance status, and quality system activity.
- Support internal audits, customer audits, and regulatory inspections by preparing records, collating evidence, tracking actions, and helping maintain a state of inspection readiness.
- Coordinate the scanning, filing, indexing, retrieval, and controlled archiving of production and quality documentation to ensure records remain accessible, legible, and appropriately retained.
- Maintain document, training, and quality system trackers and provide routine administrative support to ensure quality records and associated systems remain current and well organised.
- Support training compliance by coordinating assigned GMP and procedural training activities, maintaining records, and following up on outstanding requirements where required.
- Identify and support opportunities to improve documentation flow, right-first-time performance, review processes, data visibility, and overall quality system effectiveness within the site.
- Undertake any other reasonable duties, commensurate with the role, as may be required by the line manager and the needs of the business.
Key Working Relationships:
- Senior Quality Specialist and wider Quality team
- Production, Quality Control, Engineering and Supply Chain teams
- Internal and external auditors, customers, and regulatory representatives during audit or inspection activity
Knowledge, Skills and Experience:
- Experience working in a regulated environment, ideally within pharmaceutical, healthcare, life sciences, or other GMP-regulated operations.
- Good understanding of GMP principles, documentation standards, and the importance of data integrity and right-first-time performance.
- Experience of reviewing documents for accuracy and completeness, identifying discrepancies, and following through to resolution.
- Strong organisational skills with the ability to manage multiple tasks, prioritise effectively, and maintain attention to detail.
- Ability to work collaboratively across functions and communicate clearly with colleagues at different levels of the organisation.
- Confidence using routine IT systems and Microsoft Office applications to maintain trackers, records, and reports.
- Experience supporting quality systems such as deviations, CAPA, change controls, training records, audit actions, or document control would be advantageous.
Qualifications:
- Good general standard of education, including English and Mathematics.
- Qualification in a scientific, quality, business administration, or related discipline would be desirable.
- Relevant GMP, quality, or document control training would be advantageous.
Competencies and Behaviours:
- Demonstrates a high level of accuracy, attention to detail, and personal accountability.
- Works in a structured and organised way, with the ability to follow procedures and maintain clear records.
- Shows a proactive approach to identifying issues, following up actions, and escalating risks appropriately.
- Communicates professionally and builds effective working relationships across teams.
- Demonstrates discretion, professionalism, and a commitment to confidentiality and compliance.
- Supports continuous improvement and contributes positively to team and site objectives.
General:
- This job description is not exhaustive and may be amended to meet the changing needs of the business following discussion with the post holder.
- The post holder is expected to maintain high standards of confidentiality, accuracy, organisation, and professional communication in all quality-related activities.
- All employees are required to understand and fulfil their responsibilities relating to health and safety, data integrity, GMP compliance, and dignity at work.
Sharp is committed to being an equal opportunities employer and to building a diverse and inclusive workforce. We welcome applications from all suitably qualified candidates, regardless of age, disability, gender reassignment, pregnancy and maternity, race, religion or belief, sex, or sexual orientation.
Job Types: Full-time, Permanent
Pay: Up to £30,000.00 per year
Benefits:
- Additional leave
- Bereavement leave
- Casual dress
- Company events
- Company pension
- Cycle to work scheme
- Employee discount
- Free flu jabs
- Free parking
- Gym membership
- Health & wellbeing programme
- Life insurance
- On-site parking
- Paid volunteer time
- Referral programme
- Sick pay
- Store discount
Ability to commute/relocate:
- Tredegar NP22 5RL: reliably commute or plan to relocate before starting work (preferred)
Application question(s):
- Do you have experience of working in a regulated environment?
Work Location: In person
