Senior QC Technician Newcastle

Summary of Position

The post holder will be involved from the early stages of the project, which will involve drafting documentation, including SOPs and validation protocols for review. Executing validation protocols for the production and quality control of radiopharmaceutical products.
Upon completion of the project, the post holder will participate in the GMP-related quality assurance and quality control of PET radiotracers for clinical use. Operating a range of automated and manual radiochemical synthesis and quality control equipment. The role also involves assisting in all aspects of operating and maintain the facility to GMP standards, including documentation, equipment and laboratory maintenance, including cleaning, environmental monitoring, incoming materials management, and stock control.

Location: Newcastle.

Essential Functions

• Contributing technical knowledge and participating in the preparation and review of documentation for the build, installation, and commissioning of the PET Radiopharmacy
• Validation of equipment, production and QC processes according to approved protocols
• Following project plan and associated SOP’s as they are created to implement and build the QMS and systems
• 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 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 compliant 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
• Following GLP
• Adherence to SOP’s
• Aseptic Suite monitoring including Environmental monitoring, Radiations monitoring
• Carry out Quality Control procedures analysing the radionuclide and radiochemical purity of radiopharmaceuticals using standard analysis packages as specified in the European Pharmacopoeia
• Undertake laboratory cleaning, maintenance and procedures required for GMP analysis of radiopharmaceuticals
• Examples of duties include: preparation of chemicals including HPLC solvents for routine use; monitoring and upkeep of PET radiochemistry modules and environment; assisting with the routine monitoring of facility and equipment, supervising routine servicing of equipment, testing and maintenance of user serviceable parts; receipting goods, checking materials and performing the stock control of laboratory consumables, chemicals and gases and disposal of waste chemicals and materials
• Recording of the logs for fridge, freezers, isolator checks and all other logs
• Raising and completing deviation reports 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
• Maintain paper and electronic records from all production processes for statutory purposes, including production and quality control under GMP
• Participate in qualification/requalification exercise as required including preparing documentation and execution of protocols
• Adherence to legal and organizational procedures & guidelines about quality, safety, health and environmental issues
• Training of staff following all associated procedures and guidelines

Competencies

• GMP guidelines and quality policy
• Regulations
• Quality systems
• Accuracy
• Dedication/commitment
• Quality and compliance commitment
• Orderliness, tidiness and an eye for safety at the workplace
• Self-reliance
• Working together
• Working efficiently

Requirements

Level of professional and intellectual ability

• Knowledge of radiation (Desirable)
• Shift work required

Education/experience

• Related Science Degree
• 2–3 Years Radiopharmacy Experience
• Aseptic dispensing experience or Radiopharmacy experience or working with isolators is 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

Competencies