Head of Production

Key Responsibilities

The post holder will be responsible at an operational level for holding the licenses for the unit, which may include Manufacturer’s License (Specials) (MS), Manufacturer’s License (Investigational Medicinal Products) (MIA IMP), Wholesale Dealing Authorization (WDA), all governed by the Medicines and Healthcare Products Regulatory Authority (MHRA), and the Controlled Drugs License (Misuse of Drugs Act 1971 and Misuse of Drugs regulations (MDR) 2001 governed by the Home Office.

In collaboration with the Head of Quality, the post holder will be responsible for maintaining formal contact with the MHRA inspectors and auditors and putting in place effective corrective and preventative actions (CAPA) in response to their inspection process.

The ability to speak Welsh is desirable for this post; English and/or Welsh speakers are equally welcome to apply.

Service Delivery

• As named License Holder, to be responsible for the update and maintenance of the Site Master File, in collaboration with the Deputy Head of Production and Quality Assurance Lead, ensuring submission to the regulatory authority.
• To ensure effective participation of all unit staff in professional and multi-disciplinary service development initiatives, including benchmarking the services.
• To be responsible for the Pharmacy Technical Service’s Hazard Warning System and Urgent Pharmaceutical Medicines Information Alerts and other alerts as raised by the Medication Safety Officer network (MSO).
• To manage the unit’s compliance with Health & Safety, C.O.S.H.H. and Ionizing Radiations (Medical Exposure) Regulations ensuring the highest level of professional standards of service are provided, encompassing both quality and timeliness of service to patients.
• To evaluate highly complex range of medicine and formulation information to determine an appropriate safe, cost effective and validated method of manufacture of a medicine, including assigning an appropriate shelf life and storage conditions.
• To oversee development of distribution systems and processes under controlled conditions.
• To co-ordinate the provision of pharmaceutical approval for clinical trials of Investigational Medicinal Products (IMPs) and other medicines, through the clinical trials teams.
• To maintain safe and compliant Pharmacy Technical Services, evaluating and prioritizing services when constraints occur, and liaising and negotiating with internal and external stakeholders to maximize production.
• To review and monitor the overall workload in accordance with the capacity plan ensuring staff rotas reflect an appropriate skill mix for the allocated tasks and are an effective use of staff time, prioritizing and adjusting plans as required. This requires analysis and interpretation of a range of data unique to medicines manufacturing such as prospective and retrospective workload (including analysis of product type and manufacturing methods), staffing and facility/equipment availability.
• To be responsible for ensuring all plant and equipment planned preventative and corrective maintenance is conducted, escalating any identified risks to the Manufacturing Hub Lead.
• To monitor the outcomes of delegated environmental monitoring processes management in line with current guidance to ensure, correct action is taken in the event of a deviation and any issues shared to ensure local and national co-ordination and learning. This will include consulting with the Quality Assurance team where appropriate to resolve any validation or monitoring issues. This includes analysis of environmental data and making difficult, informed decisions with QA&C.
• To manage the effective resolution of customer complaints, product defects and recalls in adherence with Departmental, NWSSP, National and regional guidance.
• To ensure the digital systems, networks and associated tools are fit for purpose and align to national strategy, creating, designing and providing plans for improvement.

Business Planning and Service Development

•  To support the Director of Pharmacy Technical Services in developing and implementing strategic plans for the region to ensure the services provided are progressive, responsive to internal and external demand, are patient focused, safe, efficient, effective and meet regulatory compliance.
• To contribute to an agreed Integrated Medium-Term plan (IMTP) for Pharmacy Services in accordance with the organization’s guidelines and ensuring accountable staff are aware of the priorities within the strategic plan and these are reflected within the performance management processes.
• To support the Director of Pharmacy Technical Services in the strategic planning and delivery of a robust research and development program within the unit in line with the national agenda and participate in the research and development of new pharmaceutical formulations.
• To analyze and interpret clinical, technical and professional policies and NHS guidance to ensure effective, up to date standard operating procedures (SOPs) and processes are available within Pharmacy Technical Services. This will involve writing, authorizing, implementing, and reviewing SOPs on an ongoing basis. Examples might include analysis and interpretation of policies, guidance and regulations, identifying changes to regulatory and professional standards and through gap analysis identify the implications of these changes and to implement and deliver a plan to meet these standards.
• To lead and implement a range of highly complex technical research and development programs within the service. These could include supporting the development of technical services across Wales, extension of the sustainability program, automation developments and digitalization.
• To ensure business continuity plans for the provision of production services and support the other leads in maintaining their plans.
• To ensure Quality by Design (QBD) principles are implemented.

Human Resources and Training

• To be line manager for the Production Managers, supporting them in the line management of others across services and encouraging contribution from and participation by all team members.
• To provide clear direction and technical, professional and managerial leadership for accountable staff members that encourages the development of a culture of service development and continuous quality improvement using evidence-based practice to deliver patient focused services and introduce innovative service developments.
• To interpret and implement a range of professional standards for Continuing Professional Development to a diverse, professional workforce in order to deliver a timely, high quality and patient-focused service.
• In collaboration with the National Management Team, to continually review skill mix and outcome of training needs analysis to conform with National requirements whilst ensuring the most cost-effective use of staff.
• To lead and implement a range of highly complex technical research and development programs within the service. These could include supporting the development of technical services across Wales, extension of the sustainability program, automation developments and digitalization.

Communication

• To provide leadership and highly specialized medicines advice on matters relating to Aseptic Services licensed and unlicensed activities to clinicians, national auditors and regulators, where persuasive, motivational and negotiating skills are required to overcome professional challenge.
• To act as a professional role model, develop collaborative relationships with multiple stakeholders and represent the department at Divisional, NWSSP and external meetings, promoting pharmacy services development, providing and reporting back all relevant information and realizing the benefits to the local health economy that are available from joint working. These would include senior management in Health Boards and Special Authorities in Wales, professional and regulatory bodies, Welsh Government and its agencies, suppliers and professional leads within NWSSP.
• Responsible for promoting and maintaining research links with the Welsh universities.
• On a day-to-day basis communicate sometimes difficult and potentially contentious information back to the appropriate healthcare professionals where supply is impacted, and contingency planning is required.

Regulatory Compliance and Risk Management 

• To ensure effective participation of all unit staff in Quality Risk Management (QRM) principles and promote a culture of continuous quality improvement, by approving system workflows, to bring about the use of innovative new products, equipment, devices and methods of work, including clinical trials, analyzing and interpreting the requirements for service developments within the Aseptic Services Unit, and ensure highly complex validation activities are carried out for all service developments prior to introduction. Examples might include; Analysis of highly complex data unique to the manufacturing and quality assurance of medicines. Use of the information to deal with highly complex and contentious issues in manufacturing and quality assurance, internally and externally with the MHRA with regard to safety and quality of pharmaceuticals manufactured and to prevent harm to patients.
• To oversee processes to manage the risks involved in the handling of and exposure to hazardous products and waste in NWSSP e.g. Radiation protection, and cytotoxic agents, working with the national standardization agenda as developed by the National Clinical Lead Pharmacist in conjunction with Clinical Leads from the Health Boards.
• To oversee a system to prevent cross-contamination.
• To ensure that Product Quality Review (PQR) is undertaken for all licensed activity.
• To assist the Senior Quality Assurance (QA) Practitioner in all audit activities and produce written reports and statistical information and metrics with identified action.
• To ensure that the production records are evaluated, signed and retained.
• To implement quality key performance indicators reporting outcome measures to Senior Managers, NWSSP Board and external regulators.
• To ensure errors, complaints and incidents are managed within the NWSSP and the Medicines and Health Care Regulatory Agency (MHRA) guidelines.

Financial and Physical Resources 

• Delegated responsibility for income, staff and non-staff expenditures related to Production to ensure they remain within budget.
• Identify cost pressures on Production services, advise on the full range of options for dealing with them and implement any required changes.
• Identify and deliver cost reduction targets whilst minimizing the impact on quality of the service provided.
• Delegated spending authority for pharmaceutical products at an appropriate level. Ensure compliance with NWSSP’s Standing Orders and Standing Financial Instructions and ensure effective corporate governance.
• Responsible for management of appropriate storage of stocks of medicines held by the Unit.

Qualification & Requirements

Qualifications

• Essential
  • Master’s degree such as Level 7 Pharmaceutical Technology & Quality Assurance (PTQA) (Masters) or Scientist Training Program (STP)
  • Pharmaceutical Science or relevant pharmaceutical knowledge, and specialist and practical experience of GMP systems management acquired over five years (as defined by MHRA guidance) and equivalent to that required for a post-graduate diploma,
  • Management or Leadership qualification or accreditation – or demonstrable equivalent experience,
• Desirable
  • Accredited Product Approver (S10 Medical Act) and Cleanroom Supervision (CRS) accreditation,
  • Quality Improvement Accreditation

Experience

• Essential
  • Relevant post-qualification GMP experience providing NHS Aseptic services or within an MHRA licensed unit
  • Experience of Quality Risk Management (QRM) or other comprehensive pharmaceutical quality management system,
  • Experience of undertaking risk assessment, root cause analysis and CAPA, change control
  • Experience of stock management of hazardous and time-limited materials, and interpretation of stability data obtained from a range of sources,
  • Experience of managing a team of people

Skills

• Essential
  • Project management and strong organizational skills
• Desirable
  • Welsh Language

Skills and Attributes

• Good communication skills including being able to present complex information, share knowledge and influence others
• Project management and strong organizational skills, including being able to plan and document complex schedules and processes, and prioritize tasks to meet deadlines
• Capacity to think strategically and analyze, evaluate and solve complex problems
• Confident user of computer systems, demonstrating attention to detail at all levels, including utilization and understanding of spreadsheets, in order to identify, record, compare and analyze data from multiple sources.
• Approachable and professional manner, encouraging contribution from others
• Self-aware and acts with integrity
• Committed to continuing professional development for self and others,
• Welsh Language Skills are desirable levels 1 to 5 in understanding, speaking, reading, and writing in Welsh.

Other

• Deliver excellent customer service to our internal and external customers, helping us to maintain the customer service excellence standard.

Benefits

No information available.