Quality Release Officer

1. Perform and manage the operational warehouse support tasks, including but not limited to:

• Batch release activities on finished medicinal products.


• Review and approval of artwork proofs and artwork components.


• Perform quarantine release on finished medicinal products.


• Support discrepancy and damages dispositions, and non-conformance investigations for finished medicinal products.


• Review and approve warehouse stock movements.


• Upload certificates of analysis / certificates of conformance to Clinigen electronic system.


2. Support warehouse Quality Management System (QMS) tasks:

• Creation, review and approval of relevant standard operating procedures, work instructions and forms.


• Management of temperature excursions (inbound and outbound).


• Management of Product Quality Complaints


• Quality business partnering to support the business in the investigation, review and closure of quality records in the electronic QMS.


3. Ensure that appropriate standards of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) are maintained.

4. Maintain Clinigen paper and electronic records for Quality documentation, in line with Good Documentation Practise and Clinigen procedures.

Additional Duties

5. 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 with Product Recalls.


• Create artwork databases for labels.


• Participate in both internal and external audit programs, including Regulatory Inspections.


• 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.


• Support other members from the Quality team.


• Support to develop the Quality culture at Clinigen
  
  Life Sciences Graduate, Pharmacist or Chemist.


• Experience within a quality assurance role, or related.


• 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 fluently and effectively at all levels.


• Ability to self-motivate and be self-disciplined.


• Excellent IT (specifically in Microsoft-based software), planning, administrative and organisational skills


• Solution-orientated.


• Ability to be responsible and accountable.


• Ability to change priorities and act urgently as and when required.


• Excellent 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