Role:- Quality Operations Manager (QP qualified essential- Pharma) Location:- Yorkshire Salary:- Highly competitive
A fantastic opportunity for an experienced qualified QP to join a leading pharmaceutical manufacturing company in Yorkshire. You must have a demonstrable record of experience in a similar role and will be required to have direct responsibility for the Quality Operations Process Unit
- Manage the Team responsible for Quality Operations Processes Unit on site.
- To act as a Qualified Person (QP) as defined in EC Directive 2001/83 , actively contributing to the GMP Strategy for the site.
- Communicate with line management and other Departments to ensure that the Quality Operations works effectively and also ensuring that quality on the floor shop is adhered to
- To ensure that the Team reports and acts on deviations and non-conformances and follows risk assessment procedure of the impact on product quality. Additionally, identification of CAPAS and follow up, timeline and how to minimise the recurrence of the deviations.
- Execute training and operator qualifications
- To perform Regular walks on the shop floor for the continuous improvement process to ensure that the busines is meeting GMP regulations.
- Report & monitor performance of the Quality Operations on a monthly basis.
- Take part in the "Inspection Readiness Program" for the production department
- Conduct Internal and External Quality Audits in line with schedule, acting as an audit host for regulatory bodies and customers
- Work with the Site Quality Head to monitor budget
- Deal with the H&S aspects for the quality department
- BSc in either Pharmacy, Pharmaceutical Science, or a Chemistry related degree
- Qualified QP who has worked to EC/2001/83- with previous industry experience in a similar role at similar level
- Excellent understanding of pharmaceutical markets
- Team management experience
- Experience of team management and leadership
- Able to communicate at an exceptionally high standard (verbal and written)
Strategic thinker, Customer focused and commercially knowledgeable