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 & guidelines about quality, safety, health and environmental issues

Training Technicians    

-    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