Quality Compliance Section Head
GSK -
Giza, EgyptPosted 4 years ago177People have clicked1 open position
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Job Description
Job Purpose:
Provides leadership within Quality Systems functional area focusing on building and strengthening deployment of QMS, CCR, PPR,CAPA. Lead internal/external audits and to host and reply for toll manufacturers, regulatory audits.
- Key Responsibilities:
1- Auditing system:
- Ensures the deployment of audit universe with risk-based approach against QMS requirements.
- Support suppliers and TPM audits.
2- CAPA Management:
- Act as site system Lead for Track wise software for CAPA Management.
- Ensure effective CAPA closure in timely manner.
- Implement CAPA effectiveness program and sustain deliverables.
3- Regulatory inspection and compliance:
- Handle and manage site quality issues related to site compliance performance.
- Monitor site readiness for inspection.
4- QMS Implementation:
- Leading GSK-QMS policies deployment and assure their effective implementation.
- Follow up of key policies handling (Deviation handling, customer complaints, Recall, Sterile operations and validation).
- Participate in annual Quality strategy and objectives.
- Respond to Quality Alerts and QRI and ensure prevention of its occurrence in site by implementation of recommended action plans.
5- Third parties and service providers:
- Quality liaison with relevant third party manufacturing contractors.
- Quality Agreement issuance and negotiation.
6- Document management and control
- Ensure proper lifecycle management of documents through CDMS.
7- Change control:
- Act as change control Process Owner for the planned changes and review their effective implementation.
- Follow up for delivery and completion of agreed actions and resourced projects within quality parameters.
- Perform annual review for changes implementation performance and adherence.
8- CPV and PPR
- Evaluate statistically Process performance and product behavior through review of all products and process aspects in regular product review.
- Provide opportunity for identification, prioritization, and implementation of product and product process improvement through regular product review.
Job Requirements
Knowledge/ Education / Previous Experience Required:
- University Bachelor's Degree in Pharmaceutical sciences.
- 3 years of Experience in Pharmaceutical industry.
- Audit Certificate is a plus.
- Fluent in English.
- Excellent communication skills (written & verbal).
- Good presentation skills.
- High problem solving and attention to details.
- Strong influencing and negotiation skills.