Operational Quality Specialist
We are looking to recruit a Quality Specialist to join an innovative pharmaceutical manufacturing company in South Wales on a permanent basis.
The successful candidate will assist the quality management team to ensure that nearby sites are compliant with current good manufacturing practice (cGMP) in the manufacturing and packing areas.
What you’ll do:
- Ensure that products are manufactured in accordance with specified requirements and cGMP
- Conduct internal performance audits and follow up actions within site business units
- Review non-compliance identified by audit, deviations and complaints, and use technical / professional judgment to make the appropriate product quality decisions
- Ensure the review and approval of all documentation relating to manufacturing
- Assist in the hosting of Client audits
- Lead nominated regulatory compliance projects and to ensure that the business meets its regulatory commitments through satisfactory completion of these projects
- Provide statistical trending reports on quality key performance indicators and to initiate corrective and preventive actions based on this data.
- Manage team performance and absence standards, including conducting performance appraisal and setting targets and objectives for individual members of the group
- Manage and process all HR and departmental documentation for the team members including: attendance sheets, overtime forms, sickness related documents, absence request forms and annual leave and staff appraisals including 1:1s, probationary reviews and PMRs
- Supervise the work of subordinate roles in the assigned business unit or operational section, develop training plans and conduct on-the-job training of the team where required
The ideal candidate will be educated in a scientific or quality assurance discipline to degree level or equivalent, and ideally be a member of a professional body as recognised by the UK MHRA. A lower level aligned qualification plus significant QA pharma industry experience would also be considered.
The job holder will have significant experience in the pharmaceutical industry, with a diverse knowledge of various dosage form manufacturing and experience of staff supervision and management. Experience of working in a Quality Department within a cGMP/pharma environment is essential and understanding of GMP auditing to relevant quality standards with potential to perform audits is desirable
The successful candidate will have excellent analytical problem solving abilities and be able to lead by example and get results through persuasion and co-operation. Excellent written and verbal communication skills are required by the job holder as in the course of the duties.
On this occasion, LiCa Scientific is acting as an employment agency