We have an immediate opportunity with multinational pharma client in the region for Quality Assurance Specialist for a 12 month contract to ensure that the plant is operating to cGMP requirements and that processing is in compliance with regulatory filings. To liaise with the all site functions as necessary to resolve quality issues and perform batch review to permit product release.
PRINCIPAL ACCOUNTABILITIES:
1. Quality Management System (QMS)
Deviation Management system
Supervise and manage the site Deviation Management system to ensure timely and accurate recording of deviations and subsequently that an appropriate level of investigation is performed and documented to permit resolution and closure of deviations ahead of batch release.
Compliance actions (CAPA, preventive actions, audit actions)
Assure the suitability of assigned compliance actions and associated closure timelines before approval and formal entry into site systems. Monitor and drive closure rates of compliance actions for QAV and those functional areas supported as necessary to assure the overall site compliance profile is maintained.
Change Control
Support the Change Control process by assisting in the evaluation of changes ahead of approval, reviewing change controls post implementation and assessing completion of assigned actions to permit closure.
Product Quality Review
Participate in the scheduling and tracking of PQR reports required and ensure that all PQR reports are prepared on schedule and in line with site standards.
Audits and Inspections Participate in regulatory inspections, corporate and customer quality audits as necessary. Perform internal audits and external audits of suppliers as appropriate to provide necessary assurance in cGMP standards.
Quality Council
Actively present and participate in Quality Council meetings to drive quality awareness at the site and ensure management review of the QMS is achieved.
Actively trend and monitor established KPI’s at site level and ensure that support systems are maintained.
2. Site Support
Review manufacturing records for completeness and cGMP compliance to support the release process as necessary.
Review and approve plant manufacturing instructions to ensure conformity with site standards and regulatory processes
Evaluate site procedures on an on-going basis to ensure compliance. Review and approve procedures in IT support system as necessary. Prepare SOP updates as requested by quality management ensuring where appropriate that global approach is reflected.
Provide training, support and advice to colleagues on-site to facilitate cGMP improvement and best practice.
Participate in global initiatives and share knowledge both internally and externally to raise standards to meet industry best practices.
Interact with other functions on site, particularly Operations, Supply Chain, Engineering, QC and Technical Services to ensure that QAV and site goals are achieved
Participate in site initiatives such as CI projects in order to promote improvement activities and achieve goals and to further personal development.
3. Validation, Qualification and Projects
Support process, cleaning and analytical validations and equipment qualification programmes on plant as appropriate.
Review and Approve Validation and Qualification documents as necessary.
Provide QA input to various projects on site as required, e.g. introduction of new products, installation of new equipment, development of electronic systems to improve cGMP standards.
4. Product Specific Activities
Support the QP in relation to all batch release activity, primarily performing QA review of batch documents.
Liaise with CMO’s on resolution of issues relating to document errors to support release.
Act as QA contact (in conjunction with site QP) and deputise on behalf of QP where appropriate for product related quality issues and associated communications.
Act as a contact with other departments and Affiliates to support product release process and supply of post release documents.
Maintain and report Metrics relating to batch release activities.
