At a Glance
- Tasks: Ensure compliance with quality standards and support cross-functional teams in a dynamic environment.
- Company: Join Clinigen, a rapidly growing global specialty pharmaceutical company.
- Benefits: Enjoy 27 days holiday, pension contributions, and flexible benefits.
- Other info: Be part of a supportive team with excellent career growth opportunities.
- Why this job: Make a real impact on patient safety and product quality in a vital industry.
- Qualifications: Degree in Life Sciences or related field; experience in Quality Assurance preferred.
The predicted salary is between 30000 - 40000 £ per year.
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses.
Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa.
Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.
We are seeking a proactive and detail‑driven Quality Release Specialist to support our Quality and Warehouse teams.
This role plays a key part in ensuring compliance with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP), supporting the effective operation of the Quality Management System (QMS), and safeguarding product quality and patient safety.
You will work closely with cross‑functional teams, external partners and regulators, providing both technical and administrative quality support across a wide range of activities.
Key Responsibilities
- Manage day‑to‑day activities within the Quality Management System (QMS), partnering with cross‑functional teams to investigate, review and close quality records within the electronic QMS.
- Create, review and approve quality documentation, including SOPs, work instructions and forms, ensuring compliance with Good Documentation Practice.
- Maintain GMP and GDP standards, managing accurate paper and electronic quality records in line with company procedures and regulatory requirements.
- Investigate quality issues and customer complaints, working collaboratively to identify root causes, prioritise actions and implement pragmatic, compliant solutions.
- Communicate quality system requirements effectively to employees, support quality‑related training, and influence others to achieve quality objectives.
- Support internal, external and regulatory audits and inspections, including preparation, participation and completion of corrective and preventative actions (CAPAs).
- Drive continual improvement by analysing quality data, identifying process improvement opportunities, acting as a Quality stakeholder on projects, managing key supplier relationships, escalating risks to management, and supporting the wider Quality team as needed.
- Key Requirements
- Degree in Life Sciences, Pharmacy or Chemistry (or equivalent).
- Experience in a Quality Assurance or related role.
- Knowledge of GMP and GDP guidelines for human medicinal products.
- Understanding of WDA(H), MS and MIA(IMP) licence requirements.
- Strong organisational, planning and administrative skills.
- Excellent IT skills, particularly Microsoft Office.
- Confident communicator, able to engage at all levels.
- Solutions‑focused with the ability to adapt and manage changing priorities.
- High levels of accountability, accuracy and attention to detail.
- 27 days holiday plus 8 bank holidays
- Pension contributions 4.5% matched
- Life assurance 4 x annual salary
- Flexible Benefits Platform with £25/month Company contribution
- Annual salary review
- Independent financial advice service
- Enhanced Employee Assistance Programme
- Shopping discounts with retailers
- Long service awards
- Recognition scheme & employee of the year awards
Interested? We would love to hear from you, please apply today for consideration.
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Quality Release Specialist employer: Clinigen Group
Clinigen is an exceptional employer that fosters a dynamic and supportive work environment, ideal for professionals seeking to make a meaningful impact in the pharmaceutical industry. With a commitment to employee growth, Clinigen offers extensive training opportunities, competitive benefits including 27 days of holiday, and a flexible benefits platform, all while being part of a rapidly expanding global company dedicated to patient safety and product quality. Join us in our UK headquarters or at one of our international offices, where collaboration and innovation are at the heart of our culture.
