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Senior QA/QC Specialist

Date: 05-Aug-2022

Location: United Kingdom

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 design, implement and prepare the site for the analytical testing of radiopharmaceuticals, to maintain a state of GMP compliance for the QC Laboratory and support in the maintenance of the Quality management system in accordance with principles of Good Manufacturing Practice/Good Laboratory Practice.

Essential Functions

GMP/ production Compliance    -    Reviewing compliance of production and analytical methods with GMP/specials guidelines and EP, BP and/or SmPC
-     Documentation management including review and update SOPs and forms 
-    Assist with review and approval for deviations, incidents and investigations, OOS, CAPA, Change control and release of incoming materials
-    Perform / 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

Complaints/CAPA/Change Controls/Deviations    -    Assist with review and approval for  elements of the QMS including Deviations, Complaints, OOS, CAPA, Change Control, Recall, Micro Out of Specification, Risk Assessments and related trending
Quality and Compliance    -    Reviewing of the logs for fridge, freezers, QC Equipment and all other logs
-    Raising and completing deviation reports, CAPAs, Change controls, complaints, OOS and micro out of specification  where applicable
-    Participate and lead in Root Cause Analysis and CAPA identification
-    Effective communication with all colleagues to facilitate efficiency in both QC and quality related matters
-    Ensure all GMP guidelines and processes are      
-     Followed
-    Assist the QA Manager with the day to day activities, including any additional activities as delegated. 
Corporate guidelines    -    Adherence to legal and organizational procedures & guidelines about quality, safety, health and environmental issues
Training Technicians    -    Training of Technicians in SPECT and PET for QC analytical testing at HRP/LRP
QC activities    -    Accurately perform Quality Control testing on all manufactured products at the LRP/HRP according to SmPC and EP guidelines
-    Interpretation and recording analytical data and report any out of specifications ensuring appropriate action is taken in a timely manner
-    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. 
-    Liase with Quality Management on validation strategy and training. 
-    Ensuring VMP is kept up to date.
-    Ensuring there is adequate stock level required for QC activities. 
-    Maintain and organise QC equipment calibration and maintenance schedules. 
 

Requirements

Level of professional and intellectual ability
-    Knowledge of radiation (Desirable)
-    Shift work required
Education/experience
-    Related Science Degree
-    2-3 Years Radiopharmacy Experience in quality control 
Knowledge
-    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
 

Competencies

Relevant Work Experience
Communicating Effectively

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 an equal opportunity employer and believes everyone deserves respect, dignity and equality.  All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.