Production Operator / Compounder
Hours: Full time (8.30am – 5pm, Mon – Fri)
Job Type: Permanent
Reporting to: Head of Manufacturing
You will be responsible for the day-to-day compounding of pharmaceutical products, both safely and in accordance with the General Pharmaceutical Council Regulations and Guidance for Registered Pharmacies preparing Unlicensed Medicines. All activities and decisions must be supervised/ approved by the Accountable/Responsible/Superintendent Pharmacist as per Section 10 of the Medicines Act 1968.
Duties and Responsibilities
Safe and Effective Production
* Always perform the pharmaceutical compounding process by mixing excipients and medications according to a validated formula and observing Good Manufacturing Practice (GMP).
* Always follow electronic preparation methods as well as published standard operating procedures (SOPs).
* Deploy accuracy and diligence throughout the compounding process
* Strive to deliver and maintain turnaround times of production as per the company’s key performance indicators
* 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.
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.
* Assist the Production Supervisor in the training of new compounders ensuring all adhere to, champion and maintain all non-sterile compounding standards and ensuring all training and staff validation records are kept up-to-date and revised constantly as compounding processes are being updated.
* Report non-conformances to SOPs within the compounding process
* Instil a culture of no-blame, transparency and a continuous learning from non-conformances amongst colleagues.
* Assist the Production Manager in Change Control (CC) forms and Corrective
* Action/Preventative Action (CAPA) forms identified by non-conformance reports and trends.
* Write / update compounding SOPs as assigned by the Production Supervisor/Manager.
Good Stock Management
Responsible for good stock management which includes:
* Forecasting usage of SP stock for an efficient ordering process.
* Constant communication with the approved pharmaceutical suppliers to follow up on orders placed
* Ensure continuity of supply through horizon scanning and accurate stock forecasting and analysis – communicating with the approved pharmaceutical suppliers.
* Input stocks into the compounding software and ensure all certificates of analysis and any other quality control/assurance are obtained, checked by a pharmacist and filed appropriately.
* Ensure an effective stock rotation process is in place including expiry checks.
* Effective API waste management – ensuring wastage is kept to a minimum
* Assist the Production Manager in producing monthly reports for stock counts including current stock figures (stock levels and stock value)
* Participate in the safe and effective procurement process for Active Pharmaceutical APIs, Bases, Consumables and any other items required in the compounding process.
Together with the Production Supervisors and Production Manager, strive to continuously improve the service by producing, gathering and implementing initiatives using the change control process including methods of compounding, automation of process and any other process/safety initiatives.
* Participate in dispensary duties including labelling, packaging and dispensing when required
* Strive to continuously develop self and others and promote good teamwork across all areas of the pharmacy service (Patient Care Team, Dispensary, Pharmacist Team and Production)
Experience & Requirements:
* Ability to follow instructions methodically with excellent attention to detail.
* Ability to problem solve and action change effectively with minimum supervision.
* Able to work with minimal supervision
* Ability to undertake NVQ level 2 in Pharmaceutical Science
* 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