Overview
The Quality Assurance Specialist will work as part of a national team in delivering successful patient outcomes by ensuring medicines that are bought, prepared and supplied in the NHS are evidenced based, safe, and are of high quality. This will involve working closely with the pharmaceutical industry and NHS manufacturing and preparation units. The post relates to delivering a range of specialist Quality Assurance duties as part of the North West Pharmaceutical Quality Assurance team, including audit of unlicensed aseptic units, provision of advice and support, development of best practice guidance, quality assessment of medicines, project management and delivery, and workforce training and development. The SPS Quality Assurance team is seeking to recruit a highly motivated, enthusiastic and forward thinking individual to join our Hub team based at the Pharmacy Practice Unit in Liverpool, with remote working enabling candidates to reside anywhere in the NW Region and beyond.
The Specialist Pharmacy Service\'s (SPS) national Quality Assurance Service supports medicines optimisation by developing and championing best practice and by ensuring continuous improvement through the implementation of quality risk management systems in NHS medicines manufacturing, preparation and supply chain management.
Responsibilities
* Audit of unlicensed aseptic units in accordance with EL 97(52).
* Support Trusts in the design, validation and operation of clean rooms, facilities and equipment.
* Assist Trusts in applying for and maintaining MHRA Specials licences, including provision of specialist advice during MHRA inspections.
* Provide specialist advice to technical service managers regarding sterility assurance, pharmaceutical microbiology, cleanroom technology, medicines formulation, stability and process validation.
* Quality Risk Management of the Medicines Supply chain.
* Provide a highly specialist service to underpin the procurement of licensed and unlicensed medicines to NHS Trusts to optimise quality, safety and efficacy of medicines and related products used by NHS Hospitals.
* Support licensed and unlicensed medicines contracting through development of service/tender specifications and technical agreements, assessment of suppliers through audit and evaluation of quality risk management systems to ensure compliance with service specifications and regulatory requirements.
* Assess the pharmaceutical quality of medicines and medical devices and their potential for medication error.
* Evaluate scientific and technical reports relating to medicines (e.g., drug stability reports).
* Provide ongoing contract support by reviewing quality indicators and liaising with suppliers to resolve quality issues.
* Facilitate the effective communication of drug alerts and recalls from the MHRA to Trusts.
* Review and assess reports of defective medicines from Trusts, liaising with suppliers as required and submitting summaries to the national reporting system.
The Trust is committed to promoting a healthy work-life balance and welcomes flexible working requests. Not all roles are suitable for every flexible working opportunity all of the time. The organisation aims for a diverse and representative workforce and encourages applications from under-represented groups. The Trust requires that DBS checks are processed with cost recovered via salary deduction following start in post. New entrants to the NHS will commence at the first pay point of the relevant band.
Qualifications
* Masters degree in Pharmaceutical Technology & Quality Assurance OR Masters degree in Pharmacy OR equivalent experience to Masters level.
* Basic qualification in pharmaceutical sciences (BTEC) or an equivalent scientific qualification.
* Desirable: further qualification in risk management.
* Member of a recognised body (e.g., Royal Pharmaceutical Society); extensive post-qualification experience.
* Extensive experience of Good Manufacturing Practice relating to pharmaceutical manufacturing and preparation.
* Significant experience of risk management and quality management systems and their application.
* Experience of auditing and self-inspection to meet pharmaceutical regulatory requirements.
* Experience in planning and delivering training (large and small groups).
* Experience of multidisciplinary working and evidence of managing significant changes in complex environments.
* Experience and evidence of development and implementation of policies and procedures to satisfy regulatory requirements.
* Desirable: experience of quality assessment of pharmaceuticals.
* Experience of supporting outsourcing of medicines and services by the NHS; specialist knowledge of regulatory and NHS standards and guidance relating to medicines manufacture and preparation.
* Specialist knowledge of regulatory and NHS standards and guidance relating to the safe storage and supply of medicines; home care medicines services; quality risk management as applied to medicines manufacture and preparation; clean-room design, technology and operation; and pharmaceutical quality control testing methods.
* Understanding of regulatory and NHS standards and guidance relating to medicines procurement and supply; health and safety legislation as applicable to medicines manufacture and preparation.
* You must have appropriate UK professional registration.
Note: Under current Home Office Immigration Rules we may be unable to offer visa sponsorship for some roles, and there are DBS costs associated with the role as detailed in the job information.
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