Band 7/8 Executive Lead Pharmaceutical Quality Assurance

Band 7/8 Executive Lead Pharmaceutical Quality Assurance

Join Our Team as an Executive Lead in Pharmaceutical Quality Assurance/Quality Control!

Are you a seasoned professional in pharmaceutical quality assurance and control, looking to make a significant impact in healthcare? Imperial College Healthcare NHS Trust is seeking a dynamic and experienced Band 8c Executive Lead to join our dedicated team.

At Imperial College Healthcare, we are committed to delivering world-class healthcare services and pioneering medical research. As an Executive Lead, you will play a crucial role in ensuring the highest standards of pharmaceutical quality and safety, directly contributing to the well-being of our patients.

Why Work With Us?

• Innovative Environment: Be part of a leading healthcare institution renowned for its cutting-edge research and innovative practices.
• Professional Growth: We offer continuous professional development opportunities and a supportive environment to help you achieve your career goals.
• Impactful Work: Your expertise will directly influence patient care and safety, making a real difference in the lives of many.
• Collaborative Culture: Join a team of passionate professionals who are dedicated to excellence and collaborative success.

If you are ready to take on a leadership role in a prestigious healthcare setting and drive quality assurance to new heights, we want to hear from you! Apply now and be a part of our mission to provide exceptional healthcare.

Apply Today!

Main duties of the job

AIM OF THE ROLE:

To manage and co-ordinate the services and staff of the Quality Assurance/Quality Control sections of the licensed trust pharmacies and to support income-generating service contracts to other hospitals. To be the Medicines and Healthcare Products Regulatory Agency (MHRA) Specials & Investigation Medicinal Products (IMP) manufacturing license holder. To be the Wholesale Dealer License (WDL) holder. To ensure that all requirements of these licenses are adhered to. To ensure that the Department complies with all Health and Safety regulations.

About us

Imperial College Healthcare NHS Trust is absolutely committed to ensuring that our patients have the best possible experience within our hospitals. We are looking for people who are committed to delivering excellent patient care, whatever their role, and who take pride in what they do. We place a high value on treating all patients, customers and colleagues with respect and dignity, and seek people who strive for excellence and innovation in all that they do.

We value all of our staff and aim to provide rewarding careers and benefits, fulfilling work environments and exciting opportunities.

• Kind: We are considerate and thoughtful, so you feel respected and included.
• Collaborative: We actively seek others views and ideas, so we achieve more together.
• Expert: We draw on our diverse skills, knowledge and experience, so we provide the best possible care.
• Aspirational: We are receptive and responsive to new thinking, so we never stop learning, discovering and improving.

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 meet 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) for the approval of standard operating 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/QC services and plan and implement any changes to the service as a result of investigations.
• To liaise with estates staff to ensure the quality of medical gas supply (with assistance of the local gas testing specialist when necessary) and 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

• 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

• 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 out 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.