QA Compliance Section Head At GSK Egypt
Are you a QA Compliance Section Head who is energized by the challenge of being part of one of the leading pharmaceutical companies worldwide? If so, this role is the one for you to explore.
As a QA Compliance Section Head, you will be the Process Owner for Effective Implementation of QMS, QMS Structure, Content, Management and Deployment. Be the process Owner of CAPA system, CCR System, closure on VQMS. Responsible for enhancing the management process to meet company business objectives through Managing QMS implementation on site and ensuring QMS is in place and in use, and Handling internal and external Audits.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following:
Lead QMS implementation within the site to ensure that all QMS documents are assessed regarding QMS applicability and deployment.
Lead assessment of on-going effectiveness of local QMS Implementation Support the implementation and maintenance of effective quality assurance systems to ensure that quality related operations are in full compliance with GSK standards and policies.
Follow up quality KPIs, ensure quality targets are met. Support cross functional teams in QMS gap analysis through liaison with QMS Process Owners and QMS Reviewers.
Act as site inspection readiness lead for hosting customer, regulatory audits, and support site readiness to pre-inspection/ regular GMP audits through implementing extensive program including quality oversight GEMBA and in use verification of critical policies, identify and co-ordinate the activities and resources to prepare for the inspection of the site and communicate inspection readiness status to local and regional stakeholders.
Conduct internal audit runs as lead auditor and support other lead auditors in the site and ensure adherence to internal audit schedule and the completion of audit cycle in specific timelines.
Ensure the deployment of audit universe with risk-based approach against quality management system requirements and create site internal audit schedule that include all GMP activities in the site with different audit types.
Revise and monitor site internal KPIs and report monthly progress to site quality council.
Responsible on the Quality Agreements between Service providers and Third-party customers.
Manage the Changes across the site and follow up on the change actions.
Handle the Quality system forums across the site and systems review on VQMS
We are looking for professionals with these required skills to achieve our goals:
Bachelor’s degree of Pharmacy, Science, Chemistry or equivalent.
Minimum 3 – 5 Years of experience in similar role.
Up to date knowledge of current GMP, EDA Regulatory requirements, GSK QMS System.
Excellent documentation and report writing skills.
Excellent verbal and written communication skills.
Familiar with facility, utilities, Equipment and Strong experiences in cGMP/GLP compliance activities.
Good command of English and computer skills.
Self-motivation, empowerment and adaptation to business changes.
Strong prioritization and organization skills.
Able to demonstrate experience of managing diverse teams of professional staff and effective budgetary control against agreed targets.