Process Lead - Product Life Cycle Sterile API Drug Substance

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.
  
  

• 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.