QA Specialist - Specialist Pharmacy Service

Job description

Job responsibilities

Audit of unlicensed aseptic units in accordance with EL 97(52).

Supporting Trusts in the design and validation and operation of clean rooms, facilities and equipment.

Supporting Trusts in applying for and maintaining their MHRA Specials licences, including provision of specialist advice during MHRA inspections.

Providing specialist advice to technical service managers with regard to sterility assurance, pharmaceutical microbiology, cleanroom technology, medicines formulation, stability and process validation Quality Risk Management of the Medicines Supply chain

To provide a highly specialist service to underpin the procurement of licensed and unlicensed medicines to NHS Trusts w to optimise the quality, safety and efficacy of medicines and relatedproducts used by NHS Hospitals

Supporting 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, assessing the pharmaceutical quality of medicines and medical devices and their potential for medication error.

Evaluation of scientific and technical reports relating to medicines e.g. drug stability reports.

Providing on-going contract support by reviewing quality indicators and liaising closely with suppliers to resolve quality issues.

Facilitating the effective communication of drug alerts and recalls from the MHRA to Trusts.

Reviewing and assessing reports of defective medicines from Trusts, liaising with suppliers where required and submitting summaries to the national reporting system.

For full details, please refer to the attached job description

Person Specification

Qualifications

Essential

• Masters degree in Pharmaceutical Technology & Quality Assurance OR Masters degree in Pharmacy OR equivalent experience to Masters degree level
• Basic qualification in pharmaceutical sciences (BTEC) or an equivalent scientific qualification to same level

Desirable

• Further qualification in risk management
• Member of a recognised body e.g. Royal Pharmaceutical Society

Experience

Essential

• 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 the planning and delivery of training (large and small groups)
• Experience of multi disciplinary working and to have evidence to demonstrate successful management of significant changes in complex environments
• Experience and evidence of successful development and implementation of policies and procedures to satisfy regulatory requirements

Desirable

• Experience of quality assessment of pharmaceuticals
• Experience of supporting the outsourcing of medicines and services by the NHS

Knowledge

Essential

• Specialist knowledge of the regulatory and NHS standards and guidance relating to medicines manufacture and preparation.
• Specialist knowledge of the regulatory and NHS standard sand guidance relating to the safe storage and supply of medicines.
• Specialist knowledge of the standards and guidance relating to home care medicines services.
• Specialist knowledge of the principles of quality risk management as applicable to medicines manufacture and preparation.
• Specialist knowledge of clean-room design, technology and operation for pharmaceutical processing.
• Understanding of pharmaceutical quality control testing methods and their application to medicines manufacture and preparation

Desirable

• Understanding of the regulatory and NHS standards and guidance relating to medicines procurement and supply
• Understanding of health and safety legislation as applicable to medicines manufacture and preparation.

Disclosure and Barring Service Check

This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship

Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details

Employer name

Liverpool University Hospitals NHS Foundation Trust

Address

Pharmacy Practice Unit

70 Pembroke Place

Liverpool

L69 3GF

Employer's website

https://www.liverpoolft.nhs.uk/ (Opens in a new tab)