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ORGANISATION

Clinigen Limited 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 sites in Burton-on-Trent and Weybridge, with global offices in the US, EU, Australia, New Zealand, Japan, Hong Kong, South Africa, and South East Asia. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued growth. To sustain our growth, we’re on the lookout for motivated, ambitious and committed individuals to join our highly successful global team.

ROLE

The ideal opportunity for a graduate or entry into Pharma

Key Responsibilities:

• Work directly to support the Quality Specialists and Quality Manager to:
  • Ensure that appropriate standards of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) are maintained.
  • Communicate relevant aspects of the quality system to employees, as necessary, in order to support product and service quality.
  • Contribute to continual improvement by formulating reports, trending and data analysis.
  • Identify and support the implementation of process improvement opportunities, collaborating with the Business areas to form a strong and effective operational excellence team dynamic.
  • Engage with key third party suppliers, customers and clients.
  • Support key stakeholder on relevant Business projects.
  • Making decisions, solving problems and influence others in order to achieve expected responsibilities.
• Support Client audit program; This includes coordinating Client audits, and supporting Senior QA in managing audit observations/responses.
• Effectively support operational business units manage their records within the Quality Management System (QMS) including but not limited to:
  • change controls
  • non-conformances
  • CAPAs
  • risk management
• Identify root-cause of a problem, prioritise and identify solutions.
• Deal with both internal/external customers and suppliers at a technical level to investigate issues related to quality problems and customer complaints.
• Provide administrative support in the creation, review and approve relevant standard operating procedures, work instructions and forms.
• Assist in providing training to members of staff on relevant components of the QMS or procedures.
• Maintain Clinigen paper and electronic records for quality documentation.
• Able to plan effectively to meet set timelines.

• Support other members from the Quality team

Additional Duties:

• The list of duties is not intended to be exhaustive, but gives a general indication of the tasks involved. It is the nature of the company that tasks and responsibilities are, in many circumstances, unpredictable and varied. All employees are, therefore, expected to work in a flexible way when the occasion arises and acknowledge that tasks not specifically covered in their job description are not excluded, such as:
  • Support Quality Complaints (product and service) and Recalls.
  • Support the Quality Operations GMP Warehouse (where required) activities including but not limited to:
    • batch release
    • artwork proofs and artwork components approval
    • discrepancy handling
    • temperature excursions

REQUIREMENTS

• Life Sciences, Pharmacy/Pharmacology or Chemistry graduate preferred.
• Experience within a quality assurance role, or related; audit hosting/support experience would be beneficial.
• Experience of working independently and as part of a team.
• Knowledge of Guidelines on GMP and GDP of medicinal products for human use.
• Understanding on the conditions of the WDA(H), MS, MIA(IMP) licences.
• Ability to communicate at all levels.
• Ability to self-motivate and self-disciplined.
• Excellent IT, planning, administrative and organisational skills.
• Solutions-orientated.
• Ability to be responsible and accountable.
• Ability to change priorities and act urgently as and when required.
• Excellent attention to detail.

BENEFITS