QC/QA Officer Oxford

Curium Pharma; Oxford; On-site; GBP 32,000 - 45,000; Full time

Job summary

Curium is seeking a qualified professional to perform quality control on radiopharmaceuticals and assist with maintenance of the Radiopharmacy in accordance with GMP principles. The role involves ensuring SOPs are up to date, supporting deviations investigations and CAPA, and maintaining robust QMS records.

Responsibilities include reviewing GMP/EP/BP/SMPc compliance, environmental and radiological monitoring, and accurate logging of equipment and materials to sustain a GMP-compliant site in

Qualifications

• Related Science Degree is required.
• Knowledge of radiation is desirable.
• Strong attention to detail and problem-solving abilities.

Responsibilities

• Reviewing compliance of production and analytical methods with GMP guidelines and EP/BP/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 GMP compliance by keeping SOPs up to date.
• Assist with elements of the QMS including Deviations, Complaints, OOS, CAPA, Change Control, Recall, Micro OOS, Risk Assessments and related trending.
• Aseptic suite monitoring including Environmental monitoring and Radiation monitoring.
• Recording of logs for fridge, freezers, isolator checks and all other logs.
• Participate in Root Cause Analysis and CAPA identification.
• Effective communication with colleagues to ensure efficiency in production and quality matters.

Skills

Team player

Basic computer skills

Practical ability

Stress handling

Attention to detail

Education

Related Science Degree

Job description

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Location: Oxford, United Kingdom, OX3 7JU

Company: curium

About Curium

Curium is the world’s largest nuclear medicine company with more than a century of industry experience. We develop, manufacture and distribute world-class radiopharmaceutical products to help patients around the globe. Our proven heritage combined with a pioneering approach are the hallmarks to deliver innovation, excellence and unparalleled service.

With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiopharmaceutical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine. The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team.

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 trackersSupport 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 Oxford 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)

Education/experience

• Related Science Degree

Skills

• Excellent team player
• Basic computer skills
• Practical ability
• Stress handling
• Excellent attention to detail

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Equal Opportunity Employer

Curium is anequal opportunity employerand believes everyone deserves respect, dignity and equality. All applicants will be considered for employmentwithout attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Disability Confident Employer

We are proud to be a Disability Confident Level 1 employer and are committed to fostering an inclusive workplace where everyone can thrive. We welcome applications from candidates of all backgrounds, including people with disabilities.