Specialist Production Pharmacist

Main Duties and Responsibilities

Safe and Effective Production – o Together with the Director of Operations / Superintendent Pharmacist you will own the Quality Management System which translates into Quality Assurance operational excellence at the [Employer hidden — view at passion-project.co.uk] Ltd (trading as Specialist Pharmacy) – including writing, quality assuring or approving standard operating procedures.

• Supervise the Pharmacist Operations and Quality Assurance and the Lab Manager in quality assuring all compounded products ensuring:
• Product specifications are met (e.g. qualitative and quantitative including ingredient quantities and final product appearance)
• Preparation methods are correct and adhered to
• GMP standards have been upheld during the compounding process
• Physio-chemical stability data is up-to-date and accurate
• Audit trails including operator and time stamps within and outside the Compounding Software solution are maintained at all times
• Integrity and accuracy of data input of all raw materials are cross-checked against the received product and their certificate of analysis/conformity/Home Office Import Licences
• Rejected products are clearly documented in the quality management system (QMS) as well as recorded and investigated as non-conformance using the internal error management system, with a clear focus on preventing future occurrences
• Ensure data integrity standards are upheld across the documentation pathway including ALCOA+
• Provide advice to the production team on capacity and contingency planning including scheduling, considering production staff numbers, time to compound, equipment, premises and prescriber/patient demand
• Supervise the production team and act as the accountable pharmacist for production
• Strive to deliver and maintain turnaround times of production as per the company’s key performance indicators and work towards continuous improvement of the pharmacy service.
• Observe the Safety at Work Act 1974 regulations and ensure compliance with the Control of Substances Hazardous to Health (COSHH) regulations protecting staff and the general public
• Formulate or quality assure the formulation of all new preparations

Upholding Compounding Standards

• Uphold and comply with non-sterile compounding standards stated in the EU Good Manufacturing Practice, Good Laboratory Practice, Australian Pharmaceutical Formulary, British Pharmacopeia, Professional Compounding Chemists of Australia, Pharmaceutical Society of Australia standards and the United States Pharmacopeia
• Conduct internal scheduled self-audits to maintain GMP standards including premises, people, products, procedures and processes
• Act as the main investigator for all non-conformance reporting
• Instil a culture of no-blame, transparency and a continuous learning from non-conformances amongst production staff.
• Action any Change Control (CC) forms and Corrective Action/Preventative Action (CAPA) forms identified by non-conformance reports and trends
• Ensure any product recalls are managed as per regulation

Dispensary and Compounding Risk Register and Complaints

• Sign off all risk assessments of all laboratory and dispensary equipment and processes
• Sign off Change Control (CC) forms and Corrective Action/Preventative Action (CAPA) forms identified by risk assessments.
• Sign off compounding risk register together with the Pharmacist – Operations and Quality Assurance
• Draft response letters to complaints to be authorised by the director of operations /Superintendent as per the Complaints policy

Customer Service

• Supervise the Patient Care Team (PCT) in ensuring that the PCT team adheres to the following:
• Take and record customer and prescriber prescriptions accurately, quickly and politely;
• Collect the payment for the medications prescribed to customers (compounded, POM and Supplements);
• Provision of an efficient and responsive service to patients and prescribers;
• Compliance with the General Data Protection Regulations and all applicable guidelines and standards in respect of patient data;
• Work methodically and accurately with no omissions or errors;
• Reconcile and file all received original prescriptions accurately and timely
• Refer pharmaceutical queries to the Pharmacist and clinical queries to the appropriate doctor when necessary;
• Understand and apply the relevant procedures related to the escalation of specific issues based on their urgency;
• Ensure the SP office is kept orderly and clean to maximise efficiency;
• Ensure all daily parcels/letters are dispatched correctly
• Lead the Prescriber Support helpdesk working closely with the business development lead and supervising the business development and customer care support officer.

Dispensary & Procurement

• Manage the day-to-day operations of the dispensary and oversee the safe and effective procurement and stock management processes for General Sales List (GSL), Pharmacy (P) and Prescription Only Medicines (POM; licensed and unlicensed).
• Work closely with the Lead Procurement Officer to oversee the safe, timely and effective procurement of Active Pharmaceutical Ingredients (APIs) and other pharmaceutical excipients used in the compounding of pharmaceutical items under section 10 of the Medicines Act 1968.
• Ensure all procurement processes are completed in a timely manner
• Ensure all dispensary and procurement processes follow the General Pharmaceutical Council Regulations and Best Practice (as stated in the most up-to-date version of the Medicines, Ethics and Practice publication by the Royal Pharmaceutical Society), the Human Medicines Regulations 2012 and all other relevant guidance and regulations e.g. Good Distribution Practice (GDP) and the Falsified Medicines Directive (FMD; Directive2011/62/EU).

Financial and Overall Operational performance

• Produce/Quality assure monthly reports for:
• Non-conformances
• Production figures and turnaround times
• Production wastage figures including re-dos.
• Stock value for all pharmacy stock and consumables
• Courier and despatch finance figures

Service Improvement

• Together with the Director of Operations/Superintendent Pharmacist, strive to continuously improve the service by producing, gathering and implementing initiatives using the change control process including methods of compounding, new formulations automation of process and any other process/safety initiatives
• Assist the Director of Operations/Superintendent Pharmacist in building IT user requirement specifications for improving the use of the compounding software to adhere to the latest regulatory/good practice measures

Staff Management and other Duties

• Provide strong leadership and management ensuring that responsibilities and decision making are delegated appropriately, and that all staff are aware of their roles and responsibilities
• Plan, conduct, and document staff appraisals as necessary
• Conduct return to work interviews in relation to sickness and other absences
• Lead pharmacy-wide weekly meetings and communicate any changes effectively
• Participate in dispensary duties including accuracy checking final compounded products, Prescription Only Medicines (POM), Pharmacy medicines (P), General Sales medicines (GSL) and Vitamins/ Supplements.
• Participate in the pharmacist clinical checking of prescriptions
• Strive to continuously develop and promote good teamwork across all areas of the pharmacy service (Patient Care Team, Dispensary, Pharmacist Team and Production)
• Supervise and Manage the education and training of all staff in the pharmacy ensuring that they have the necessary training carry out their tasks competently.

Skills Required

• Ability to problem solve and action change effectively with minimum supervision
• Ability to follow instructions methodically with excellent attention to detail.
• Able to work with minimal supervision
• GPhC-registered Pharmacist
• Basic computer skills essential
• Flexible and adaptable to meet the needs of SP, e.g. accommodating for part time / shifts would be required
• Production/Compounding experience is highly desirable

Colleagues at Gluck Holdings Ltd should be ….

• Customer Focused, at the forefront of providing service excellence.
• Action Oriented, able to take on new challenges with enthusiasm.
• Trustworthy, able to gain the confidence and trust of others easily and honour commitments.
• Innovative, able to spot opportunities to do things better and share best practice.
• Collaborative, building and maintaining strong working relationships and working with colleagues to meet shared goals.
• Cultivating Innovation, embracing the concept that the business should never stand still, challenging the status quo and not settle for anything but #1.
• Strategically Minded, comfortable to shift their thinking between the short and long term to lead us towards future success.
• Collaborative, modelling collaboration at all levels and promoting high visibility of shared contributions to goals.