Quality Compliance Section Head At GSK
Job description
Site Name: Egypt – Giza – Giza
Are you a leader by nature? Are you a Quality Systems expert who is energized by the idea of playing a key role within the Quality Compliance team in on of the leading pharmaceutical companies worldwide? If so, then this Quality Compliance Section Head opportunity is the one for you to explore.
As a Quality Compliance Section Head, you will provide leadership within the Quality Systems functional area, focusing on building and strengthening deployment of QMS, CCR, Quality alerts, CAPA. You will lead internal/external audits, host and reply to toll manufacturers, regulatory audits and audit and assurance. You will enhance management processes to meet company business objectives through Managing QMS implementation on site and ensuring QMS is in place and in use. You will be the process owner for the effective implementation of QMS, QMS Structure, Content, Management, Auditing, CAPA, CCR systems and Deployment. You will act as the QMS Champion across all site operations and as a point of contact to provide support/training/coaching for QMS Process Owners and QMS Reviewers.
This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following
Auditing system:
Internal audit and self-inspection Process Manager.
Ensures the deployment of audit universe with risk-based approach against QMS requirements.
Support suppliers and TPM audits.
CAPA Management:
Act as site system Lead for Trackwise software for CAPA Management.
Ensure effective CAPA closure in timely manner to maintain monthly green dashboard.
Implement CAPA effectiveness program and sustain deliverables.
Regulatory inspection and compliance:
Act as Site inspection readiness Lead hosting audits.
Handle and manage site quality issues related to site quality compliance performance.
Monitor site readiness for inspection.
Ensure local and global regulatory conformance and alignment.
QMS Implementation:
Lead GSK-QMS policies and PGSOPs deployment and assure their effective implementation.
Follow up of key policies handling (Deviation handling, customer complaints, Recall, Sterile operations, risk management, document and data management & control change and validation).
Participate in annual Quality strategy and objectives (QIP).
Provide oversight and governance to ensure quality standards are effectively implemented in manufacturing sites across the GSK Network.
Respond to Quality Alerts and QRI and ensure prevention of its occurrence in site by implementation of recommended action plans
Document management and control:
Ensure proper lifecycle management of documents through Veeva.
Change control:
Act as change control Process Owner for the planned changes and review their effective implementation.
Manage and lead all projects related to all change initiatives e.g. commercial, R&D, Technical and supply.
Follow up for delivery and completion of agreed actions and resourced projects within quality parameters.
Escalate deviations from the plan
Perform annual review for changes implementation performance and adherence.
Quality risk model champion for the site to manage local and regional communications for the site model
Prepare and approve quality improvement plan and ensure implementation of the plans
Prepare the site master file to be ready for regulatory and customer inspections
Manage customers quality agreement and TTS
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
Degree in Pharmaceutical sciences
4-5 years of experience within the pharmaceutical field
Quality systems background
Strong leadership skills
Learning agility
Good communication skills
Multitasking