Validation Section Head

4 weeks ago

Cairo, Egypt GSK Full time

**Site Name**: Egypt - Cairo

**Posted Date**: May 7 2024

**Job Purpose**

Manage and ensure the implementation of validation activities as per mandated requirements and policies.

Maintain the validation status for systems through validation lifecycle management, validation review plans (when applicable) and management monitoring.

Ensure validation/Qualification systems are in an inspection readiness state.

**Key Responsibilities**:
Support in achieving site/department goals and projects by participating in Site Validation master plan creation and taking the accountability to ensure the right first time implementation of systems/projects.

Process Validation/Qualification:

- Create Process validation master plans for different dosage forms.
- Overall, understating product lifecycle management, participating in PLM Stage 1 and ensuring prerequisites to Stage 2.
- Develop, design and create process validation protocols with the appropriate acceptance sampling plans for statistical decision-making.
- Analyze, document, and approve validation summary reports to ensure the implementation of stage 2

Cleaning Validation:

- Create and develop cleaning validation master plans, risk-based rationales and cleaning risk assessments to define the cleaning validation program.
- Create and approve cleaning validation protocols and reports.

Holding time studies:

- Create Holding time validation master plans, rationales, protocols and reports as per WHO Technical Series 992,2015

Maintain the validation status for systems through effective validation review and maintenance plans.

Ensure systems inspection readiness by leading and Participating in process confirmation Gemba and management monitoring runs.

Ensure compliance with data integrity requirements and be responsible for DI implementation within validation systems to ensure that the requirements are in place, in use, and effective.

When needed, support equipment process/utility qualification by preparing required validation life cycle documents according to validation lifecycle, computer system validation and Data integrity requirements.

When needed, support ITMS Qualification with the above sites, approve and witness ITMS validation activities. And conduct related ITMS validation review plans.

**_ Why you?_**

**Basic Qualifications**
- We are looking for professionals with these required skills to achieve our goals:_
- Bachelor's degree in Pharmaceutical Science
- Knowledge of product design, PLM and pharma dosage forms
- Knowledge of SAP, Statistics (or any alternative statistical tool)
- From 3 - 5 years of experience in Validation/Production and/or Operational Quality
- To gain knowledge of process measurements and validation readiness
- Good Command of English language

**Preferred Qualifications**:

- If you have the following characteristics, it would be a plus:_
- Teamwork
- Decision Quality
- Situational Adaptability
- Production Knowledge
- Analytical thinking
- PLM knowledge
- Report writing
- Good Strategic planning
- Good Negotiation skills
- Good Communication and organization skills
- Courage and accountability

**Job Posting End Date**:
**14.05.2024**

**Why GSK?**

**Uniting science, technology and talent to get ahead of disease together.**

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

**Contact information**:
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