Qc/Qa Officer Newcastle

Curium Live Forward; Newcastle upon Tyne; On-site; GBP 42,000 - 60,000; Full time

Job summary

Curium Live Forward is seeking a Quality Control professional to perform QC on radiopharmaceuticals and assist with maintenance of the Newcastle Radiopharmacy in line with GMP. You will review production methods against EP/BP/SmPC guidelines, update SOPs, and support deviations, CAPA and QMS activities.

Skills include teamwork, attention to detail, good communication, and the ability to manage logs and environmental monitoring. Shift work is required; related science degree preferred.

Qualifications

• Requires a related science degree and quality control experience are desirable.
• Desirable radiopharmacy experience; working knowledge of pharmaceutical chemistry and GMP is required.

Responsibilities

• Quality control on radiopharmaceuticals in compliance with GMP/EP/BP/SmPC
• Review and update SOPs and forms
• Assist with deviations, incidents, investigations and CAPA activities
• Review QC tests and microbiology results and manage Out of Specification results
• Maintain quality records and trackers; ensure GMP compliance across the site
• Support QMS elements including deviations, complaints, CAPA, change control and recalls
• Conduct environmental monitoring and aseptic suite activities including isolators
• Record logs for equipment, fridge/freezer and other QA checks
• Participate in root cause analysis and CAPA identification
• Communicate effectively to enhance production and quality processes

Skills

Team player

Basic computer skills

Customer relations

Communication skills

Practical ability

Timekeeping

Stress management

Attention to detail

Education

Related Science Degree

Quality Control experience desirable

Radiopharmacy experience desirable

Knowledge of GMP

Job description

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