Responsibilities
* Participates in day-to-day management of the Quality Management System and ensures rigorous compliance with GMP in QMC and City Standard Operating Procedures.
* Takes an active role in supporting the Quality Assurance manager in the upkeep of a central computer QMS database for the unit organisation.
* Supports the Quality Assurance team in the upkeep of a central computer Documentation database for the unit organisation.
* Facilitates investigations into Quality events and non-conformances, ensuring root cause analysis is undertaken and preventative measures are identified to prevent re-occurrence.
* Provides guidance on the assignment of appropriate corrective and preventative actions to all levels of staff within NUH.
* Participates in the evaluation of complex change requests from NUH and assigns actions to ensure that changes do not impact on the safety, quality or efficacy of QMC products.
* Supports the senior QA team during self-inspection audits and agreement of corrective action plans with the relevant section head.
* Provides support and guidance in the review system to ensure all QMS reports are reviewed for successful implementation of corrective and preventative actions.
* Prepares and carries out validation protocols closely with the QC team.
* In collaboration with the QA Manager and other senior staff, ensures all activities in the department are carried out in accordance with the principles of GMP, ensuring that all medicines manufactured are of the required quality, safety and efficacy.
* Take minutes at Quality and Distribution meetings.
* Participate in document control including copying, issuing, scanning, distributing documents both internally and with external parties.
* Support Production and Stores in the management and completion of CAPAs.
* Perform effectiveness review of changes, deviations, complaints, risk assessments and escalate any concerns to the QA manager, responsible person or the Production manager.
* Participate in the release of raw materials/Unlicensed Medicines.
* Provide support to releasing officers in conducting audits and the implementation of actions required to address deficiencies in various departments: Production, Stores, Quality assurance, Quality Control and Radiopharmacy.
* Support QA/QC in the calibration of data loggers, temperature mapping of fridges, rooms and incubators.
* Carry out routine temperature mapping of temperature controlled equipment and areas within Pharmacy Stores. Prepare mapping reports and investigate any issues (if required).
* Ensure all preventative measures are assigned with achievable timeframes.
* Ensure that all change requests are assessed and processed in a timely manner.
* Support where needed to NSM (Non-Sterile Manufacturing) with product release activity to ensure release of tablet packed products meet the required manager times.
* Ensure that accurate computerized records are maintained to facilitate senior management decision making.
* Contributes in identifying action plans to achieve cost savings within QC/QA/Stores.
* Help to maintain staff awareness of QMS systems and ensure the system is efficient.
* Participates in the training of staff in Quality Assurance and QMS.
* Participates in presenting on a monthly basis to all section heads and senior management on the progress of the QMS using Microsoft software.
* Reviews Standard Operating Procedures within QA / Pharmacy Stores and the wider QMC and CITY hospital sites, in accordance with the procedures.
* Regularly reviews the training manual within the QA / Pharmacy Stores department.
* Assists in the maintenance of the quality document management system ensuring production, approval, issue and review of documents is performed in a compliant manner.
* Identifies and participates in training and development opportunities to support Continuing Professional Development.
* Complies with Trust and departmental policies relating to security and patient confidentiality ensuring that procedures are carried out in accordance with safe systems of work and current legislation.
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