Validation Section Head

Job Description

Site Name: Egypt - Giza - Giza Posted Date: Apr 26 2022 Are you looking for an opportunity to manage projects, identify areas of improvement and support safety working practices? If so, this is the job for you. As a Validation Section Head, you will manage and ensure the implementation of Pharmaceutical Validation activities in regards to Process validation, Cleaning validation, Bulk holding time validation , Air system & Water System qualification and media fill runs. You will maintain the validation status for systems through validation lifecycle management, validation review plans (if applicable) and self inspections. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Create and maintain an up to date Site validation master plan 1- Pharmaceutical Validation a. Cleaning Validation Create a Cleaning Validation Master Plan or an equivalent document to define the cleaning program Create a Cleaning Risk Assessment for each machine and Determine the controls to mitigate any identified risk(s) and the need to dedicate facilities or equipment Document the justification and rationale for the cleaning approach Document and approve a protocol prior to the start of each cleaning validation or verification exercise. Document and approve cleaning validation report and oversight the cleaning process and ensure proper In Place and In Use aligned with the validation study b. Process Validation & Bulk Holding Time Create a Process Validation Master Plan (NPI, or an equivalent document to define the manufacturing process elements Participate in Technical Risk Assessments (TRA?s) and relevant production trials as a support to technical team Participate in creation and maintenance of Product Control Strategy Participate in the process of CPV and ensure process robustness Document and approve a protocol prior to the start of each PQ study or verification exercise. Document an approve Process validation report and oversight the process and ensure proper In Place and In aligned with the validation study Create BHT protocols for finished products and/ or dispensed raw materials as per policies and WHO technical requirements. c. Media Fill Initial Process/Line Aseptic filling Validation. Generate the Media fill validation protocols and Report. Ensure that environmental systems and supporting equipment (e.g. autoclaves, container/stopper washers, and depyrogenation ovens/tunnels) have been appropriately validated. Conduct validation runs. Ensure that media fill process is conducted as per issued protocol Accumulate, compile, and evaluate all test results. Prepare the validation report, attach the completed media fill filling log sheet to it and circulate for approval. Ensure that all environmental systems and supporting equipment remain in compliance through change control, calibration, and preventative maintenance programs. Assist Operational Quality in investigation reports for media fill when a positive result is obtained. Lead the communication with above site when needed. To record video tape for the whole media fill run and to archive all video records. Submit agreed CAPAs to Compliance department to be uploaded on Carisma3 after conducting meeting of ?Learning and Actions? with all concerned departments. d. Air & Water System Qualification Create air & water system Qualification protocol To ensure performance of environmental control validation testing defined in this protocol. To review validation engineering testing results, viable and non-viable counts results. To prepare the final report and circulate for approval. e. Ensure that GMP principles are applied to guarantee quality of supplied products when it comes to validation activities f. Perform self inspection audits for validation department. g. Participate in the gap analysis on relevant QMS policies, identify gaps between in-place and in-use. h. Review and trend analysis for Environmental results obtained and interpretation of results. i. Support in implementation of aseptic Media Fill Policies j. Support in sterile capability improvement program. k. Participate in sterile related control and project involvements. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors of Pharmaceutical Sciences Minimum of 5 years of experience in quality department Knowledge of product design , validation and sterile filling operation 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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