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Validation Section Head

4 months ago

مصر, Egypt GSK Full time

**Site Name**: Egypt - Giza - Giza

**Posted Date**: May 7 2024

**Job Purpose**

Manage pharmaceutical validation activities regarding process validation, cleaning validation, air system qualification, and media fill runs.

Execute the validation life cycle within GSK systems and departments to ensure GXP systems comply and are validated.

**Key Responsibilities**:
**Manage pharmaceutical validation activities in regard to process validation, cleaning validation, air system qualification, and media fill runs**:

- Prepare and update the site validation master plan (SVMP).
- Ensure all process and cleaning validation testing required for new and existing equipment and products are implemented according to process and cleaning validation plans.
- Ensure that all air system qualification and media fill runs are conducted according to qualification plans.
- Follow up validation review practices for scheduled equipment and products, review the validation review reports, and follow up completion of relevant action plans.
- Ensure completion of all validation work required for specific change control requests up to their final closure.
- Adhere to company EHS/GMP policies and follow up local rules. In addition, GPS tools should be made the most of for effective information search and ongoing improvement in ways of working.

**Executing the Validation Lifecycle for all new and existing GxP systems according to QMS**:

- Determine the impact of the equipment/system on GMP processes through Compliance Determination.
- Create and execute validation lifecycle documentation such as (MBP, PRA, CD, URS, DQ, IQ, OQ, PQ, and VSR) as per CSQMS, AEQMS, and ITQMS depending on the type of systemValidate excel sheets.
- Perform Periodic Validation Review to maintain and review the validated status of the systems.
- Decommissioning of GxP systems and Excel Sheets.

**Responsible for planning and prioritizing the validation activities through the Validation Master Plan**:

- Maintain and review Site System register to ensure all mandatory fields are entered and the systems are accurately recorded.
- Reflect the outcome of (SSL) site system list into (VMP) validation master plan

**Confirming DI requirements are met in the design of new and existing system against ITMS, QMS &SOPs**:

- Management of data backups system passwords
- Managements of users and administrative functions for the different systems

**Responsible for the continuous improvement and standardization of the validation activities/documentation**:

- Maintaining a robust documentation and archival system.
- Maintain an inspection ready status ahead of any internal and external audits for validation activities.

**Supporting the validation capability of the site**:

- Delivering of periodic validation training for all site staff.

**Participate/coordinate the execution of validation testing with other departments and suppliers.**

**_ Why you?_**

**Basic Qualifications**
- We are looking for professionals with these required skills to achieve our goals:_
- Bachelor's degree in pharmacy or science.
- 3 - 5 years' experience in the pharmaceutical industry.
- Knowledge of QA/QC and production activities.
- Fluent English is essential (written, spoken, and read).
- Computer skills.
- Good communication skills.
- Analytical thinking and problem-solving.

**Preferred Qualifications**:

- If you have the following characteristics, it would be a plus:_
- Set Direction & Inspire
- Work Across boundaries
- Release Energy
- Develop Capability and Talent
- Drive Performance
- Live our value

**Job Posting End Date**:
**17 May 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**:
**Important notice to Employment businesses/ Agencies