Validation Manager

Job Description

Site Name: Egypt - Cairo Posted Date: Sep 13 2022 Are you a Quality/ Operations professional who is looking into progressing their career within one of the leading pharmaceutical companies worldwide? If so, then this opportunity is the one for you to consider. As a Validation Manager you will be responsible to manage and ensure the implementation of process validation, bulk holding time validation, cleaning validation and ITMS as per mandated requirements and policies. You will also 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: Maintain all validation activities in an inspection ready state for any internal and external audits to ensure successful inspection and acting as the site SME for any Validation related topic. Approve the validation documents for the validation life cycle (e.g. SVMP, VMPs, VPs, VSRs, Equipment and Analytical Qualification documents and Department?s SOPs). Accountable for the maintenance of the Equipment Qualification, packaging validation, Computer system validation, lab equipment Qualification and Cleaning validation plans to be updated and aligned with the Regulatory updates requirements. Ensure the effective implementation of the Computer system validation (CSV) lifecycle. Identify, develop and train successors for the role, and coach others in his/her area of expertise, ensuring other functions (e.g. operations) have enough product knowledge and understanding to execute their roles. Depute the Site Quality Head in his absence. Responsible for achieving the department?s goals in terms of safety, quality, supply adherence and cost optimization. This applies and not limited to: - Ensuring the implantation of the QMSs in the department (e.g. Deviations- change control, risk management, etc.). - Maintaining safe environment for self and other team members at workplace. - Adherence to release plan for any validation batches. - Achieving project timelines. Support GPS implementation for managing validation different activities. Approve and revise the Equipment validation life cycle and its documents (e.g. URSs, IQ, OQ, PQ, VSR, decommissioning documents and Thermal mapping). Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors degree in Pharmaceutical Sciences or Engineering. 5-7 years of experience in Quality or Operations within the pharmaceutical or engineering industry. Up to date knowledge of current GMP, EDA Regulatory requirements, GSK QMS System and CSV / DI requirements. Excellent report documentation, trending and report writing skills. Excellent verbal and written communication skills. Expert in IQ, OQ, PQ, facility, utilities, Equipment and Strong experiences in cGMP/GLP compliance activities Experienced in handling regulatory interfaces such as inspections. 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. 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