To support the Head of Quality and Quality Assurance Manager with the development, implementation and maintenance of quality standards and systems to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs.
Project Planning / Co-ordination:
- Together with the Quality Assurance Manager, actively plan Quality Assurance functions requirements; ensuring major milestone targets for each project are visible to all team members and key stakeholders to achieve on time market entry.
- Together with the Quality Assurance Manager, determine tasks and resources required to deliver each project milestone and deliverables.
- To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
- Ensure high quality output - Vigilantly watch over job processes, tasks and work products to ensure freedom from errors, omissions or defects.
- Initiate action to correct quality problem and notify others of quality issues as appropriate. If a procedure does not exist, devise one, (through the appropriate channels); if a process needs amending, do so through the appropriate channels.
- To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Highlight opportunities for system optimisation to team members.
- To ensure review of all QC and production batch documentation when required and correctly in order to achieve a high level of customer service and cGMP.
- To ensure preparation of Submission Documentation in support of licence applications
- Coaching / Mentoring - support members of team with problem solving and skill development to aid learning and early problem resolution.
- Recruitment - assist with recruitment of team members in line with resource requirements and to job spec.
- Ensure that Product Reviews are scheduled and that the schedule is maintained and adhered to.
- Technical Agreements:
- Ensure that customer/ Contract services Technical Agreements are initiated and maintained.
- Ensure that SAP material changes are reviewed for correct updates and ensure SAP QA metrics generated monthly
- Ensure that all customer requests are dealt with within a reasonable timeframe and are extensive.
- Ensure Commercial Meetings are attended and related trackers are maintained and timelines are agreed and achieved.
- Ensure that Quality Management System meeting schedule is established and maintained and that QA are present to facilitate these meetings
QA/ QP release:
- Ensure that the Batch documentation, Laboratory results and related Quality Systems are correct and approved prior to any QA/QP release required
Self Inspection Program:
- Ensure Self Inspection Program is maintained
- Manage and Lead/ Participate in outside Inspections (Customer audits / Regulatory inspections)
* Qualified to a minimum of degree level, preferably a Science degree incorporating Quality Assurance
* 5 years' experience working in a Quality Assurance role in a manufacturing environment with a minimum of 2 years in a team lead/supervisory role.
* Lead Auditor qualification complete
* Supervisory Management qualification an advantage
* Experience in managing a team of direct reports required
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.