QA/QC Officer

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

• Reviewing compliance of production and analytical methods with GMP/specials guidelines and EP, BP and/or SmPC.
• Documentation management, including reviewing and updating existing SOPs and forms, as well as writing new SOPs.
• 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.
• Support the writing of QC validation/verification protocols.
• Perform the execution of QC analytical method validation and verification protocols.
• Support the maintenance of the Equipment calibration, Requalification and Validation Logs.
• Support the scheduling of Calibration, Requalification and Validation activities.
• Support the maintenance of the Supplier Qualification systems.
• Support in the performance of Supplier Qualification.

Complaints/CAPA/Change Controls/Deviations

• Assist with elements of the QMS, including Deviations, Complaints, OOS, CAPA, Change Control, Recall, Micro Out of Specification, Risk Assessments and related trending.

Quality and Compliance

• Recording of the logs for incoming material, fridge, freezers, isolator checks and all other logs.
• Raising and completing deviation reports OOS and MOOS where applicable.
• Participate in Root Cause Analysis, CAPA/Change control identification and effectiveness check completion.
• 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.
• Participate in the Gemba walk and Self inspection.
• Ensuring that all assigned training is completed within the specified time frame.
• Ensuring that QC equipment calibration checks are up to date.
• Participate in the provision of QMS data for the preparation of Quality Management Reports.

Corporate Guidelines

• Adherence to legal and organizational procedures and guidelines about quality, safety, health and environmental issues.
• Training of Technicians in SPECT QC, PET QC, and GFR processing once qualified.

QC Activities

• Accurately perform Quality Control testing on all manufactured products (SPECT & PET) at the LRP according to SmPC, EP guidelines and internal procedures.
• Reviewing the completed incoming material forms.
• Manage the Environmental Monitoring process and ensure data are recorded and entered on the trends spreadsheet.
• Reading Microbiological plates, broth, and sterility samples.
• Interpretation and recording of Microbiological data and report any out of specifications, ensuring appropriate action is taken on time.
• Review and maintain QC logbooks and data to ensure the site meets all its objectives in relation to the data integrity policy.
• Support validation activities, preparation, and execution of protocols.
• Liaise with Quality Management on validation strategy and training.
• Ensuring VMP is kept up to date.
• Maintaining the tidiness of the QC Lab.

Set up Production Orders

• Setting up orders for the purchase of QC materials.
• Checking the stock level of QC materials.

Requirements

Knowledge of radiation (Desirable).

Shift work required.

Education / Experience

• Related Science Degree.
• 2-3 Years of Radiopharmacy Experience.
• Radiopharmacy experience or Laboratory experience is desirable.
• Analytical and Excel skills are desirable.
• Validation and Protocol execution experience is desirable.
• Experience of working within the Quality Department is desirable.

Knowledge

• A working knowledge of pharmaceutical chemistry and good manufacturing practice is required.
• Working knowledge of performing equipment qualification and process validation (Desirable).

Skills

• Excellent team player.
• Basic computer skills.
• Good customer relationship skills.
• Communication skills.
• Practical ability.
• Excellent timekeeping competencies.
• Stress handling.
• Excellent attention to detail.

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.