Technical Section Head

Job Description

Site Name: Egypt - Giza - Giza Posted Date: Aug 17 2022 Job Purpose Support and/or lead the technical aspects of a product during product transfer, product trouble shooting and change assessment, in accordance to regulatory requirements and GSK standards ensuring that the product is delivered on time to the highest levels of quality and robustness. Support in implementing technical elements of the product lifecycle on site comprising Technical Risk Assessment (TRA ) Key Responsibilities: Technical section is expected to provide support and/or leadership and establish key partnerships across Operations, Technical, Quality, Supply, Engineering and Commercial Regulatory for the technical project(s) for which he/she is accountable. Provide technical leadership and input into root cause analysis to support/lead the investigation and resolution of product complaints, product deviations and PPR investigations in conjunction with Quality. Provide technical input to regulatory submissions for technical projects, including new SKUs and products under composition change. For new SKU and product undergone technical change in process and/or composition; provides technical advice to key stakeholders ensuring that operators have appropriate product knowledge and training to fully execute the changed / optimized manufacturing instructions. Provides technical leadership during product transfer from/to GMS ensuring a robust, well understood process is transferred with a well-defined and appropriate Product Control Strategy. Accountable for implementing technical elements of the product lifecycle through leading, facilitating and review the required TRAs and prepare/ Review the PCS reports in planned dates. Ensure that Product Control Strategy (PCS), as an outcome from TRA, is shared with validation department to be used as input and integral part of Performance Qualification protocol issuing. Conduct required technical trials and summarize technical outcomes at the end of the performed technical activity. Lead material/process/product change assessment from technical perspective ensuring robust, compliant implementation of change and continuity / security of products? supply. Ensure that Safety, Quality and continuous improvement are supported. Why you? Basic Qualifications: Education and Experience: Bachelor?s degree of Pharmacy 5-7 Years experience at pharmaceutical industrial organization; preferably a multinational one. Has detailed knowledge of at least single dosage form including unit operation understanding, device/packaging processes, plant equipment and analytical testing with general knowledge in other dosage forms. Experienced in improving products, processes and trouble shooting. Experienced in product transfer, with an understanding of the product development phase. Proven track record of expertise in delivery/participating in technical risk assessments. Has a thorough knowledge of GMP requirements, SOPs, regulatory guidelines, and policies. Knowledge or experience of using statistics. Demonstrates ability to contribute effectively to influence matrix teams and colleagues in other functions. Flexibility in work schedule. Excellent interpersonal skills. Excellent command of English language. Excellent team working skills with the ability to communicate at all levels. 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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