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Process Lead
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Ras Al-Khaimah, United Arab Emirates Julphar Full timeAt Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism. Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal...
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Process Lead
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Ras Al-Khaimah, United Arab Emirates Julphar Full timeAt Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism. Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal...
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Process Lead
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Ras Al-Khaimah, United Arab Emirates Julphar Full timeAt Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism. Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal...
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Process Lead
2 weeks ago
Ras al-Khaimah, United Arab Emirates Julphar Full timeAt Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism. Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal...
Process Lead
2 weeks ago
At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism. Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees. Key Responsibilities - Responsible for the process and cleaning validation documents and oversight the execution activities for the Sterile Facilities (Biotech, Liquid Injectable, Lyophilized and Sterile powder filling). - Responsible for the Process Validation of Sterile Manufacturing and API biological drug substance. - Familiar with the Biosimilars API Drug substance processing, and fill finish. - Shall be aware of the standards mentioned as per EU annex -1 requirements. Familiar with the Cleaning Validation of API drug substance as per the PDA TR 29. - Responsible for the designing of Aseptic process simulation study. Preparation of Protocols and reports. - Support lifecycle monitoring and continued process verification (CPV) based on trend data and product performance. - Design and execute cleaning validation protocols using a risk-based approach and scientifically justified acceptance criteria (e.g., MACO, PDE-based limits). - Address cleaning of equipment used in multiproduct facilities and define appropriate cleaning frequencies. - Conduct in-process, bulk product, and clean/dirty equipment and area hold time studies to establish validated holding periods and ensure no impact on product quality. - Justify clean hold and dirty hold times as per industry guidance and support with microbial and visual inspection data. - Lead packaging component and process validation for sterile and biotech dosage forms including vials, Ampoules to ensure container‑closure integrity, sterility assurance, label accuracy, and compliance with global regulatory expectations. - Perform risk-based cross-contamination assessments in compliance with EU and WHO guidelines. - Design and execute transport validation protocols including temperature mapping, route qualification, and simulation studies to validate packaging during shipping and storage. - Familiar with the filter Validation Requirements in the sterile process. - Responsible for the Visual inspection Qualification process. - Investigation of the incidents, OOS, returns goods and all manufacturing related non-conformances with respect to validation. - Review of change controls, CAPAs and deviations related to qualification and validation. Act as Quality general in EQMS to complete the actions associated with qualification and validation activities. - Monitoring the CAPA effectiveness related to validation. Core Competency - In terms of competency, you are highly result oriented with strong sense of accountability & ownership. - Ability to prioritize, multi-task and work effectively under pressure to meet deadlines. - Good communication, interpersonal and collaboration skills. - Highly disciplined and must be organized, self-motivated to learn new learnings and implement them at workplace - Technical expertise required for the Qualification and Validation in Sterile and Biotech plants. - Good implantation skills and easily adapt to changing situations. - Must be able to work in a cross-functional environment interacting with other internal and external departments - Must be able to communicate technical, scientific, and regulatory information, both written and verbally. Qualification/Functional Knowledge - Bachelor’s or master’s degree in pharmacy, Chemistry, Biotechnology, or related field. - 8–10 years of experience in pharmaceutical validation with a focus on solid oral dosage forms. - Proven expertise in process, cleaning, packaging, transport validation, and hold time studies. - Sound knowledge of EU GMP, FDA, WHO, ICH Q8–Q10, Annex 15, PICS, and GAMP 5. - Strong command of QRM principles, data integrity, PDE/MACO calculations, and QMS documentation. - Experience with regulatory inspections (USFDA, MHRA, EU, TGA, ANVISA) preferred. Excellent leadership, communication, documentation, and cross-functional coordination We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to read more about us and the journey of Julphar #J-18808-Ljbffr
