Reporting to the QA TPN Release Pharmacist
Main Purpose of the job:
The role is responsible to provide the following:
1. Quality Assurance support throughout the compounding center to ensure that the quality of products produced consistently complies with the GMP and regulatory requirements and will be safe and effective to the end user.
2. To support the QA TPN Release Pharmacist to ensure continuous change and adaptation of systems in line with new rules and regulations.
3. To support the QA TPN Release Pharmacist to instill a culture of quality throughout the compounding center and uphold the company's Quality Policy.
Key Performance Areas:
Daily walkabouts and reporting of QA issues in the compounding center:
Perform daily walkabouts in the compounding center and prompt reporting to the QA TPN Release Pharmacist/ Production Pharmacist any quality issues that have been noted.
Validation and media fill:
Ensure that validations are carried out as per SOP and according to the yearly schedule ,i.e. checking relevant production paperwork is completed accordingly and checking of acid solution dilutions.
Ensure that the media fills are performed as per SOP and according to the yearly schedule.
Ensure the compounding process is followed as per approved SOPs
Ensure equipment that is utilized in the Compounding Center is within calibration
Daily QA Manufacturing activities:
Record drop test information daily and ensure the integrity of all isolators is properly maintained.
Observe leak tests when performed.
Approve bio-decontamination cycles to start by verifying all the pre-bio-decontamination checks.
Authorize the off-loading of product from transfer isolators and emergency drums by checking the time the solution was drained, the remaining acid solution and acid condensate and calculating the acid vaporization rate.
Ensure checked documentation is fully complete.
Monitor the pressure for all isolators throughout the production processes and report any OOS to the QA TPN Release Pharmacist/Production Pharmacist.
Perform regular daily audits on transfer isolators, emergency drums and waste bins to verify that docking procedures, off-loading of components, care of the equipment (workstations, gloves, transfer isolators and their support structures.) pressure requirements (MAN sterilizers, transfer isolators, workstations) and GMP standards are maintained as per SOP.
Checking of BMRs and BRLS in line with production planning for correct Expiry date etc.
Sign for other compounding center related documents and logs where QA-IPQC signatures are required.
Accurate hand-over to and from the night shift.
Observing vigilance within the compounding center-use of IPA, correct gowning and overall adherence to SOPs
Documentation:
Ensure accurate documentation of all QA checks in the compounding center.
Ensure appropriate filing of all QA log sheets (i.e. isolator inspection logs, DPTE logs, pre-filter logs, pressure drop and leak test logs and sterilization logs) and that the filing is up to date.
Correct filing/archiving of production records and maintain record stores.
Ensure good documentation and record keeping practices.
GMP adherence and staff training:
Ensure adherence to correct hygiene, gowning dress code and related regulations including no eating, chewing of gum, drinking and smoking in classified areas.
Knowledge and adherence of latest GMP regulations
Staff Supervision and after hour service:
Be available for duty after hours and on required Production weekends to complete related QA-IPQC duties until production is completed.
Continuous supervision of production staff on quality matters.