Local Operating Company Quality Executive At GSK
Key Responsibilities:
QMS Champion within Egypt LOC, supporting QMS implementation by:
Conducting QMS Committee to ensure cascading all updates to LOC staff and reviewing SOPs in place/in use compliance status.
Assigning GAP Analysis teams and following up to ensure completion within due dates.
For new generation QMS; Adoption of newly issued PGSOPs in the local SOP system within due dates.
Ensure the risk areas in relation to QMS activities within the LOC are identified and the risks are appropriately assessed and escalated to local/regional Quality Council meetings and RMCB as required; as well as proper development and follow-up of mitigation plan(s).
Conducting QMS training for LOC staff as required.
Support in the creation and implementation of the Quality plan aligned with regional objectives for Egypt in liaison with LOC quality manager.
Following up on Quality KPIs for Egypt LOC to ensure that Quality targets are met & any improvement plans are developed.
Contribute in the preparation of the quality councils and scribing meeting minutes for Egypt LOC in liaison with LOC quality manager.
Attending Regional Quality Council meetings and support in preparation as required.
Ensure implementation and maintenance of effective quality assurance systems within Egypt LOC and ensure that quality related operations are in full compliance with GSK standards and policies, regulatory requirement, good storage and distribution practices as follows:
Managing Self inspection system; responsible for agreeing/defining self-inspection universe, maintaining schedule, conducting audit runs, writing audit reports and following-up on CAPA implementation.
Managing Internal Audit System, responsible for defining internal audit universe, maintaining schedule, conducting audit runs and writing audit reports for all functions within LOC affecting product quality.
Change Control Management within Egypt LOC, responsible for holding panels to ensure appropriate assessment of proposed changes and following-up on assigned action items to ensure effective implementation of all changes.
Deviation System Management, responsible for handling deviations related to GSK imported products within Egypt LOC and the storage/distribution practices for all GSK local products in Egypt after release from the manufacturing sites and ensuring appropriate development of CAPA plan and following-up on its implementation.
CAPA System Management within Egypt LOC, responsible for CAPA plan development, agreement and follow-up, document closure evidence and escalate CAPAs that are not completed within the agreed dates to ensure effective closure of all CAPAs.
Customer Complaint System owner within Egypt market, responsible for communicating with complainants to ensure data and sample gathering, liaising with manufacturing sites to conduct investigations and provide the appropriate feedback to the complainant. Also responsible for reviewing and analyzing complaint performance trending and liaising with manufacturing sites to work on the repeated issues.
Support in Incidents and Recalls Systems Management within Egypt LOC in liaison with LOC quality manager, responsible for holding LIC/PIRC, conducting investigations to determine root cause, assessing the impacted products disposition, and ensuring the carry out of effective recalls whenever needed.
Release of Finished goods in Egypt LOC, responsible for quality release of all imported products.
Review and approve overprinting and repacking activities.
Ensure the risk areas in relation to QMS activities within the LOC are identified and the risks are appropriately assessed and escalated to local/regional Quality Council meetings and RMCB as required; as well as proper development and follow-up of mitigation plan(s).
Technical Terms of Supply System owner within Egypt LOC, responsible for setting and updating TTS between GSK supplying sites and LOCs to ensure the compliance of the distribution process with all regulatory requirements.
Setting Quality Agreements between Egypt LOC and third-party manufacturing sites, service providers and distributors.
Conducting audits on Third party contractors in liaison with Consumer to ensure compliance of storage and distribution of GSK products.
Quality Regulatory Intelligence Management within Egypt LOC, ensuring the compliance with the up-to-date regulatory requirements and that the LOCs are informed of relevant developments and trends, by performing assessment for any received QRI and assigning CAPA plan to close any gaps and conducting QRI quarterly committee in liaison with GMS sites.
Quality Alerts Management within Egypt LOC, responsible for accepting or rejecting all GSK quality alerts, conducting assessment, and developing CAPAs for any identified gaps.
Regulatory Inspection Management, responsible for preparing LOC Quality for any regulatory inspection to ensure all regulatory/GXP requirements are fulfilled.
Job Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Pharmacy Graduate
Fluent English is essential (written, spoken, and read).
Must be computer literal.
Very good communication skills.
Good leadership skills, analytical thinking, and problem solving.
Good observer, with auditing skills
Good knowledge of the QMS and its implementation.
Strong understanding of and experience in Quality Assurance systems particularly in the areas of Deviation Handling, Change Control and management, Self-Inspection, CAPA management, Finished goods Storage & Distribution.
Strong knowledge of GDP & GSP requirements.