- 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.
- 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.
- 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.
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Process Lead - ras al khaymah - Julphar
Description
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 ResponsibilitiesExcellent leadership, communication, documentation, and cross-functional coordination
We value people from different backgrounds. Could this be your story? Apply today or visit to read more about us and the journey of Julphar
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