J3698KentPharmaceutical Permanent£70,000 to £85,000 per annumFull Time06/07/2017Quality Assurance – Qualified Person (QP)
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Qualified Person (QP)
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.
KEY DUTIES AND RESPONSIBILITIES: 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.
Qualifications 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
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.