Qualified Person

£70000 to £85000 per annum
06 Jul 2017
03 Aug 2017
William Blohm
Contract Type
Full Time
Qualified Person (QP)

Qualified Person

We are looking for a professional Qualified Person (QP) to deliver effective, safe and compliant management of the Quality Assurance function of the aligned area(s) within the organisation framework.

Ensure that products are manufactured in accordance with GMP, Standard Operating Procedures and all other pertinent regulatory requirements.

Execute Qualified Person (QP) responsibilities.
Develop and drive improvements in KPI's, plans, targets and your personal/team objectives.
Proactively drive and react to system trending (e.g. deviations, complaints and environmental management) to ensure ongoing quality performance.

Establish and maintain effective communication with clients to ensure that the management of complaints and queries takes place to match internal and external client expectations.
Maintain thorough understanding of international regulatory guidance, ISO, corporate and client requirements pertinent to the site, and to ensure that all work within the Quality department and across the aligned cell complies with these and with departmental procedures.

Manage completion of all documentation (GMP, statutory and regulatory) to the required standard and timescales, to ensure timely and efficient service for our internal and external clients.

Maintain a state of readiness for regulatory agency and third party audits.

Ensure new products, equipment and processes are effectively introduced to internal & external standards.

Ensure appropriate staff training and development programmes are in place and implemented to assure competency (suitably qualified and experienced personnel) and support the achievement of objectives.
Authorize and/or prepare scientific and technical documentation as required.

Minimum Degree in Chemistry, Pharmacy or Microbiology

Eligible to act as a Qualified Person' as defined in 2001/83/EC and 2001/82/EC (as amended)
Working knowledge of the principles and guidelines for GMP and other relevant regulations
Up to date understanding of regulatory expectations
Excellent scientific and technical knowledge
Capable of working to deadlines and prioritize multiple tasks
Excellent written and verbal communication skills to internal and external stakeholders
Attention to detail
Flexibility to meet changing needs and priorities of the business
Well organised with logical and methodical approach to work
Ability to work effectively as part of a team
Ability to problem solve and use good judgement
Even tempered, positive person, approachable

Key Words: Qualified Person / QP / Quality Assurance Professional / Batch Release / GMP Quality / Quality Assurance / Contract / Sterile / Aseptic / Biologics

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors and is made up of a collaboration of scientists supporting science. We look forward to helping you with your next career moves.