Summary of Position
Ensure site compliance with the Specials guidelines, the current international pharmaceutical legislation and related guidelines, along with company requirements. Support a culture of excellence for the site.
Shift work required.
NOTE: The vacancy is a maternity cover (fixed-term contract).
Essential Functions
GMP/ Production Compliance
- Review compliance of production and analytical methods with GMP/specials guidelines and EP, BP and/or SmPC.
- Documentation management: review and update existing SOPs and forms, and write new SOPs.
- Assist with deviations, incidents and investigations, OOS, CAPA, change control and release of incoming materials.
- Review QC tests and Micro results, manage out‑of‑specification results.
- Ensure timely completion and update of all quality records and trackers.
- Support the site to remain GMP‑compliant by ensuring SOPs are up to date.
- Write QC validation/verification protocols.
- Execute QC analytical method validation and verification protocols.
- Maintain equipment calibration, requalification and validation logs.
- Schedule calibration, requalification and validation activities.
- Maintain supplier qualification systems and support supplier qualification performance.
Complaints/CAPA/Change Controls/Deviations
- Assist with QMS elements such as deviations, complaints, OOS, CAPA, change control, recall, micro out of specification, risk assessments and related trending.
Quality and Compliance
- Record logs for incoming material, fridge, freezers, isolator checks and other logs.
- Raise and complete deviation reports OOS and MOOS where applicable.
- Participate in root cause analysis, CAPA/change control identification and effectiveness checks.
- Communicate effectively with colleagues to facilitate efficiency in production and quality matters.
- Ensure all GMP guidelines and processes are followed.
- Inspect incoming materials as part of quality inspections.
- Participate in Gemba walk and self‑inspection.
- Complete assigned training within the specified time frame.
- Ensure QC equipment calibration checks are up to date.
- Provide QMS data for preparation of quality management reports.
Corporate Guidelines
- Adhere to legal and organisational procedures & guidelines concerning quality, safety, health and environmental issues.
- Train technicians in SPECT QC, PET QC and GFR processing once qualified.
QC Activities
- Perform quality control testing on all manufactured products (SPECT & PET) at the LRP according to SmPC, EP guidelines and internal procedures.
- Review completed incoming material forms.
- Manage environmental monitoring process and record data on the trends spreadsheet.
- Read microbial plates, broth and sterility samples.
- Interpret and record microbiological data; report out‑of‑specifications and take appropriate action in a timely manner.
- Review and maintain QC logbooks and data to ensure site meets objectives in relation to data integrity.
- Support validation activities, preparation and execution of protocols.
- Liaise with quality management on validation strategy and training.
- Keep VMP up to date.
- Maintain tidiness of the QC lab.
Set Up Production Orders
- Set up orders for the purchase of QC materials.
- Check stock levels of QC materials.
Requirements
Knowledge of radiation (desirable)
Shift work required.
Education/Experience
- Relevant science degree.
- 2–3 years of radiopharmacy experience.
- Radiopharmacy or laboratory experience desirable.
- Analytical and Excel skills desirable.
- Validation and protocol execution experience desirable.
- Experience working within the quality department desirable.
Knowledge
- Working knowledge of pharmaceutical chemistry and GMP required.
- Knowledge of equipment qualification and process validation desirable.
Skills
- Excellent team player.
- Basic computer skills.
- Good customer relationship skills.
- Communication skills.
- Practical ability.
- Excellent time‑keeping competencies.
- 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 an equal opportunity employer and believes everyone deserves respect, dignity and equality. All applicants will be considered for employment without attention to race, colour, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
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