Quality Assurance Specialist
2 days ago
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.
The list of duties is not exhaustive, but gives a general indication of the tasks involved. 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
- 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
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