Engineering Validation Section Head

Job Description

Site Name: Egypt - Giza - Giza Posted Date: May 10 2022 Are you a professional Validation Engineer who is energized by the challenge of being part of one of the leading pharmaceutical companies worldwide? If so, this Engineering Validation Section Head role is the one for your to explore. As an Engineering Validation Section Head, you will execute the validation life cycle within GSK systems and departments to ensure GXP systems are in a complying validated state & act as a CSV lead for the Site managing Data Integrity requirement (e.g. Audit Trail Review, Admin user and Back up activities). This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: 1 - 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, VSR) as per CSQMS, AEQMS, ITQMS depending on the type of system Verify the Validation of excel sheets & Validate excel sheets (If necessary) Perform Periodic Validation Review to maintain and review the validated status of the systems Decommissioning of GxP systems and Excel Sheets 2 - Acting as the CSV Lead for Giza Site responsible for: ATR & Back up Process Owner Admin user for all lab equipment Extract audit trail and review with lab/production teams the content and ensure the gaps are closed (Trackers) Back up the lab/production equipment software and data Review the DI assessment after completion by system owner and mitigate the gaps Record ATR and Back up KPIs and report to DI champion Raise capability of system owners for effective review of audit trail Review ATFA and ensure that is reflected in ATR tracker Review access maps for lab/production equipment System owner for password Manager Software 3 - 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 4 - Participate/ Coordinate the execution of validation testing with other departments and suppliers 5 - 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 6 - 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 7 - Supporting the validation capability of the site Delivering of periodic validation training for all site staff Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor?s Degree in Engineering Minimum of 5 years of experience in a similar position Good knowledge of data integrity requirements Good planning and coordination, problem solving and time management skills. Strong Analytical Skills & Team Work Good interpersonal and communications skills. Ability to work under stress and to manage conflicting priorities. Production Knowledge & experience in sterile operations is a plus. Excellent command of English language Why GSK? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Health, strengthening our leadership, and transforming our commercial execution. Now, we?re making the biggest changes we?ve made to our business in over 20 years. We?re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science; and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent and technology to get ahead of disease together ? all with the clear ambition of delivering human health impact; stronger and more sustainable shareholder returns; and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients ? so we deliver what matters better and faster; accountable for impact ? with clear ownership of goals and support to succeed; and where we do the right thing. So, if you?re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. Contact information: You may apply for this position online by selecting the Apply now button. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSKs commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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