QC/QA Officer Newcastle

Summary of Position

To perform quality control on radiopharmaceuticals and assist with maintenance of the Radiopharmacy in accordance with principles of Good Manufacturing Practice.

Essential Functions

• Reviewing compliance of production and analytical methods with GMP/specials guidelines and EP, BP and/or SmPC
• Review and update SOPs and forms
• Assist with deviations, incidents and investigations, OOS, CAPA, Change control and release of incoming materials
• Review QC tests and Micro results, managing Out of specification results
• Ensure timely completion and update of all Quality records and trackers
• Support the site to ensure it is GMP complaint by making sure SOPs are up to date
• Assist with elements of the QMS including Deviations, Complaints, OOS, CAPA, Change Control, Recall, Micro Out of Specification, Risk Assessments and related trending
• Sanitation and transferring of consumables in the aseptic suite and isolators
• Cleaning the isolators and Radiopharmacy facility according to SOP’s
• Aseptic Suite monitoring including Environmental monitoring, Radiation monitoring
• Recording of the logs for fridge, freezers, isolator checks and all other logs
• Raising and completing deviation reports OOS and MOOS where applicable
• Participate in Root Cause Analysis and CAPA identification
• Effective communication with all colleagues to facilitate efficiency in both production and quality related matters
• Ensure all GMP guidelines and processes are followed
• Goods in check/inspection as part of quality inspections of incoming materials
• Adherence to legal and organizational procedures & guidelines about quality, safety, health and environmental issues
• Training of Technicians in QC
• Accurately perform Quality Control testing on all manufactured products at the Newcastle Radiopharmacy according to SmPC and EP guidelines
• Manage Environmental Monitoring process and ensure data are recorded and trended in the QMS - Reading Microbiological plates, broth and sterility samples
• Interpretation and recording of Microbiological data and report any out of specifications ensuring appropriate action is taken in a timely manner
• First line maintenance of equipment
• Review and maintain QC logbooks and data to ensure the site meets all its objectives in relation to data integrity policy
• Responsible for validation activities, and preparation and execution of protocols
• Setting up production orders in the system
• Checking stock level and ordering products

Requirements

Level of professional and intellectual ability

• Knowledge of radiation (Desirable)
• Shift work required

Education/experience

• Related Science Degree
• Quality Control Experience desirable
• Radiopharmacy Experience desirable
• working knowledge of pharmaceutical chemistry and good manufacturing practice is required

Skills

• Excellent team player
• Basic computer skills
• Good customer relation skills
• Communication skills
• Practical ability
• Excellent timekeeping competences
• Stress handling
• Excellent attention to detail