Band 7/8 Executive Lead Pharmaceutical Quality Assurance

Job description

Job responsibilities

MAIN TASKS AND RESPONSIBILITIES:

1. Leadership

To provide clinical and professional leadership to pharmacy QA/QC services and research staff, in accordance with the pharmacy priorities and objectives.

To identify and promote best practice

To motivate and inspire others

To ensure that issues relating to QA/QC services including changes in practice are communicated to all pharmacy staff as appropriate

To work collaboratively with pharmacy staff and management, to ensure implementation of local and nationally agreed pharmacy services objectives

To ensure that operational policies are kept up to date with legal and professional developments

To set standards, operational guidelines and safe systems of work. To monitor the compliance with these and ensure action is taken in the event of failure

2. Operational Management

To manage and co-ordinate the work of pharmacy QA/QC services.

To ensure that the QA/QC practices meets the requirements of national guidelines (e.g. the requirements of Good Laboratory Practice (GLP))

To liaise with the Medicines and Healthcare Products Regulatory Agency (MHRA) for all licensed pharmacy activities

To manage in conjunction with the Deputy Chief Pharmacist(s), the qualification, commissioning and validation of new facilities and equipment

To be responsible with the Deputy Chief Pharmacist(s) the approval of standard operation procedures in all areas covered by licensing

To be responsible with the Deputy Chief Pharmacist(s) for the development and management of a robust Quality Management System (QMS) and to be responsible for the maintenance of records, the effective management of non-compliance reviews, implementation and management of agreed actions plans

To provide expert advice and technical input into investigations and quality risk management issues

To act as a Releasing Officer as and when required

To undertake internal Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) audits of the Trust licensed premises and those who hold SLAs with us

To be responsible for the effective management of the Change Control and Unusual Event programme ensuring improvements and any regulatory changes are assessed and implemented

To act as the pharmacy contact for the national and regional alerting systems and co-ordinate action on medication alerts within the trust

To investigate and report on defective medicines

To provide expert advice on pharmaceutical matters

Maintain trust procedures for supply of unlicensed medicinal products

To undertake risk management, ensure compliance with medicines legislation and ensure patient safety

To undertake investigations into the quality/effectiveness/economy of QA/AC services and plan and implement any changes to the service as a result of investigations

To liaise with estates staff to ensure ;

o The quality of medical gas supply (with assistance of the local gas testing specialist when necessary).

o The maintenance of clean room facilities within the pharmacies.

3. Staff Management

To support, develop and monitor the progress of all QA/QC staff.

To manage accountable staff

To set objectives and undertake performance reviews and appraisals in accordance with departmental guidelines

To manage staff attendance, performance, disciplinary and grievance issues

To be responsible for the recruitment of all QA/QC staff

To support continuing professional development for all pharmacy staff

4. General Management

To be responsible for the staffing budgets and the procurement, maintenance of equipment and resources within pharmacy QA/QC services

To advise on the suitability and purchasing of equipment for aseptic services

To monitor service level agreements ensuring agreement, renewal and invoicing

To ensure that appropriate systems are in place for the investigation of complaints, accidents and untoward incidents relating to pharmacy QA/QC services

To personally contribute to the delivery of education programmes

To identify own training needs

To participate in other areas of pharmacy practice in order to ensure a broad base of pharmaceutical knowledge

5. Research and Development

To lead, develop and support pharmacy related research programmes

To support the Chief Pharmacist and other senior pharmacy staff in promoting the Trust and the Pharmacy Departments Research and Development programmes

To undertake, supervise and give guidance on the reconstitution of pharmaceutical clinical trial materials used with the Trust

To contribute to the preparation and publication of reports where required

6. Other

To undertake continual professional development and maintain a CPD portfolio including continuing education and attendance at appropriate courses and study days

To participate in all relevant departmental, trust and external meetings and contribute to effective communication within the department

To be a member of the Pharmacy Executive and senior pharmacy management team

To undertake any other duties commensurate with the grade as requested by the Chief or Principal Pharmacist

To be aware of and apply, relevant legislation such as the Health and Safety at Work Act, Control of Substances Hazardous to Health, GLP, GMP and Medicines' Act

Person Specification

Experience

Essential

• Comprehensive working experience in a managerial capacity in a licensed GMP facility
• Thorough understanding of GMP, GCP, WDL and the requirements of the MHRA
• A good understanding of current microbiological or chemical methods and instruments used in QA/QC
• An excellent understanding of equipment and techniques used in aseptic manufacturing or compounding
• Releasing Officer

Qualifications

Essential

• EDUCATION
• Degree in Pharmacy or other relevant subject (e.g. Chemistry, Microbiology) to Masters level
• SKILLS/ABILITIES
• Ability to think strategically, develop services and manage change
• Ability to identify risk and carry our risk assessments
• Ability to analyse and solve problems
• Ability to set targets and meet deadlines
• Ability to appropriately recommend, substantiate and communicate decisions and influence senior staff
• Ability to promote & develop a quality work environment and ethos
• Good personal organisation, time management and meeting skills
• A good understanding of national and local priorities

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.

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

Imperial College Healthcare NHS Trust

Address

The Bays

S Wharf Road

London

W2 1NY

Employer's website

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