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Quality Release Specialist - Byfleet, United Kingdom - Clinigen
Description
Key Responsibilities:
1.Effectively manage the operational tasks within the Quality Management System (QMS), including Quality Business Partnering with other departments to support the investigation, review and closure of records within the Clinigen electronic QMS.
2.Create, review and approve relevant standard operating procedures, work instructions and forms.
3.Able to plan effectively to meet set deadlines.
4.Able to work collaboratively to identify root-causes of a problem, prioritize and propose pragmatic, compliant solutions.
5.Ensure that appropriate standards of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) are maintained.
6.Maintain Clinigen paper and electronic records of Quality documentation, in line with Good Documentation Practise and Clinigen procedures.
7.Make decisions, solve problems and influence others in order to achieve expected responsibilities.
8.Deal with both internal/external customers and suppliers at a technical level to investigate issues related to quality-related matters and customer complaints.
9.To communicate relevant aspects of the quality system to employees, as necessary, in order to support product and service quality.
10.Participate in and support internal, external and Regulatory audits and inspections. This includes delivery of audit corrective and preventative actions.
11.Assist in providing training to members of staff on relevant components of the QMS or procedures.
12.Contribute to continual improvement by formulating reports, trending and data analysis.
13.Identify and support the implementation of process improvement opportunities, collaborating with the business areas to form a strong and effective operational excellence team dynamic.
14.Manage the relationship and operational duties with key third party suppliers, customers and clients.
15.Escalate to management when product quality or patient safety is at risk.
16.Act as a key Quality stakeholder on relevant business projects.
17.Support other members of the wider Quality department, as required.
Additional Duties
18.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:
oManage temperature excursions (inbound/outbound)
oManagement of Product Quality Complaints
oCreate artwork databases for labels.
oPerform batch release activities on finished medicinal products.
oReview and approve artwork proofs and artwork components.
oPerform quarantine release on finished medicinal products.
oPerform product recall activities, including the support of mock recalls
oSupport discrepancy and damages dispositions, and non-conformance investigations for finished medicinal products.
oCreate, review and approve warehouse stock movements.
oUpload certificates of analysis / certificates of conformance to Clinigen electronic system
oSupport the Quality Operations Warehouse activities including but not limited to:
batch release
artwork proofs and artwork components approval
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
