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Quality Compliance Section Head

GSK
Giza, Egypt
Posted 4 years ago
177People have clicked1 open position
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Job Details

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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.

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