To perform Quality Control functions within the Material Receiving, Label Control, Distribution and Production areas in order to assure material and products are sampled and released in compliance with agreed specifications and timelines.
Responsibilities:
Quality Control functions within Material Receiving:
- Perform incoming goods sampling, inspection and approval.
- Ensure any customer specific requirements have been carried out by Logistics during booking-in and Quality Control during the approval process.
- Sample materials upon customer request.
- Carry out expiry and status changes of materials upon request.
- Travel abroad when required to aid the inspection, approval and sampling of materials for Almac Clinical Services.
- Ensure Sampling areas are cleaned and perform area clears after sampling has been completed.
- Ensure Almac Clinical Services adherence to cGMPs, SOPs and Customer instructions through performance of job function.
- Monitor storage area environmental conditions.
Quality Control functions within Label Control and Distribution:
- Inspect and approve Clinical Labels prior to issuance to packaging operations, distribution and direct dispatch from Almac Clinical Services. Record results electronically.
- Perform electronic inventory transactions to make labels available to Production.
- Advise Label Control and Distribution personnel on accept / reject criteria and on general issues.
- Approve Label Verification projects used to perform a fully automated inspection of labels.
- Approve randomisation files for use by the label verification system.
- Apply and remove electronic holds on distribution orders.
- Perform verification checks on documentation and clinical material prior to distribution from Almac Clinical Services.
- Approve Depot Shipment paperwork.
Quality Control functions within Production:
- Perform regular in-process quality checks on products, processes, room layout and safety to ensure compliance with GMP and Almac Clinical Services procedures Perform end of operation documentation checks and associated electronic transactions.
- Advise Production personnel on accept/reject criteria and on general issues.
- Review log books and perform facility inspections.
- Instruct Production personnel on cleaning methods and perform area clearance checks, this includes the corridors and changing areas.
- Perform sampling and Inspection operations as requested.
- Perform calibration checks on balances and scales used in the Almac Clinical Services facility.
- Accompany Almac approved contractor when performing Environmental Monitoring.
- Travel abroad when required to aid the inspection of labelling operation.
- Perform inspection on JTM related activities e.g. printed clinical labels, labelled clinical materials and review JTM batch documents.
In General:
- Perform Destruction duties as required.
- Assist in client audits.
- Instruct relevant personnel on cleaning methos in the event of spillage.
- Monitor environmental conditions in storage and production areas. Alert QC Supervisor / Manager immediately when there is an excursion of environmental condition.
- Assist with the allocation and prioritising of duties for Materials Receiving, QC Label Control & Distribution and Production personnel.
- Check documentation for completeness and accuracy. Identify any deviations from written procedures and inform relevant personnel.
- Assist and deputise for the Quality Control Supervisor.
- Contribute to the review and writing of quality procedures, including the development of new SOPs and revision of existing SOPs.
- Assist with training and development of QC Materials Receiving, QC Label Control & Distribution and Production personnel.
- Attend meetings when required.
Criteria:
- Diploma in sciences or life sciences discipline
- Knowledge of GMP
- Excellent verbal and written communication skills
- Ability to demonstrate a logical approach to problem solving
- Ability to use initiative and to prioritise tasks
- Ability to work to consistent high standard under pressure
- Be willing to train others when required
- Ability to demonstrate strong attention to detail
