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Quality Assurance Specialist

2 months ago

West Byfleet, Surrey, United Kingdom Clinigen Full time
Job Title: Quality Release Specialist

At Clinigen, we are seeking a highly skilled Quality Release Specialist to join our team. As a key member of our Quality department, you will play a critical role in ensuring the quality and integrity of our products.

Key Responsibilities:
  • Manage operational tasks within the Quality Management System (QMS), including Quality Business Partnering with other departments to support the investigation, review, and closure of records.
  • Create, review, and approve relevant standard operating procedures, work instructions, and forms.
  • Plan effectively to meet set deadlines and work collaboratively to identify root-causes of problems, prioritize, and propose pragmatic, compliant solutions.
  • Ensure that appropriate standards of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) are maintained.
  • Maintain Clinigen paper and electronic records of Quality documentation, in line with Good Documentation Practise and Clinigen procedures.
  • Make decisions, solve problems, and influence others to achieve expected responsibilities.
  • Deal with internal and external customers and suppliers at a technical level to investigate quality-related matters and customer complaints.
  • Communicate relevant aspects of the quality system to employees to support product and service quality.
  • Participate in and support internal, external, and Regulatory audits and inspections, including delivery of audit corrective and preventative actions.
  • Assist in providing training to members of staff on relevant components of the QMS or procedures.
  • 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.
  • Manage relationships and operational duties with key third-party suppliers, customers, and clients.
  • Escalate to management when product quality or patient safety is at risk.
  • Act as a key Quality stakeholder on relevant business projects.
  • Support other members of the wider Quality department as required.
Additional Duties:

The list of duties is not exhaustive, but gives a general indication of the tasks involved. All employees are 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.

  • Manage temperature excursions (inbound/outbound)
  • Management of Product Quality Complaints
  • Create artwork databases for labels
  • Perform batch release activities on finished medicinal products
  • Review and approve artwork proofs and artwork components
  • Perform quarantine release on finished medicinal products
  • Perform product recall activities, including the support of mock recalls
  • Support discrepancy and damages dispositions, and non-conformance investigations for finished medicinal products
  • Create, review, and approve warehouse stock movements
  • Upload certificates of analysis/certificates of conformance to Clinigen electronic system
Requirements:
  • Life Sciences Graduate, Pharmacist, or Chemist
  • Experience within a quality assurance role or related
  • Experience of working independently and collaboratively as part of a team
  • Knowledge of Guidelines on GMP and GDP of medicinal products for human use
  • Understanding of the conditions of the WDA(H), MS, MIA(IMP) licences
  • Ability to communicate effectively at all levels
  • Ability to self-motivate and self-disciplined
  • Excellent IT (specifically in Microsoft-based software), planning, administrative, and organisational skills
  • Solutions orientated
  • Ability to be responsible and accountable
  • Ability to change priorities and support urgencies as and when required
  • Excellent attention to detail
Benefits:
  • 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