Process Lead Product Life Cycle Oral Solids

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

• Lead the preparation and execution oversight of process validation and cleaning validation activities for oral solid dosage forms including tablets, capsules, and granules.
• Responsible for process validation of manufacturing steps like granulation (wet/dry), blending, compression, encapsulation, coating, and packaging.
• Responsible for designing and executing cleaning validation activities for oral solid dosage manufacturing using a risk-based approach aligned with current regulatory guidelines, including FDA, EMA, WHO, ICH Q9(R1), and PDA TR 29 & 49. Ensure scientifically justified acceptance limits based on PDE/HBEL, MACO calculations, and visual cleanliness studies. Address multiproduct equipment cleaning strategies, define clean and dirty hold times supported by microbiological and analytical data, and maintain the Cleaning Validation Master Plan (CVMP) to ensure compliance with global regulatory expectations and readiness for inspections.
• Execute hold time studies for bulk materials, intermediates, and equipment cleaning (clean and dirty hold times), ensuring alignment with current GMP and industry standards.
• Support continued process verification (CPV) by reviewing trend data, in-process controls, and product performance metrics to ensure lifecycle process robustness.
• Lead packaging process validation for oral dosage forms including blister packing, bottle filling, and carton packaging to ensure accuracy, label compliance, and product integrity during storage and transport.
• Design and implement transport validation protocols to assess product stability under simulated and real-world shipping conditions (temperature, vibration, humidity).
• Responsible for providing the support for qualification and validation of equipment used in oral solids manufacturing including granulators, mixers, tablet presses, capsule filling machines, coaters, and blenders.
• Conduct risk assessments to manage cross-contamination, shared equipment use, and cleaning effectiveness, aligned with EU, WHO, and FDA guidelines.
• Manage and investigate incidents, deviations, OOS, and complaints related to validation activities. Ensure closure through effective CAPA implementation and change control.
• Act as Quality representative in EQMS systems for validation-related activities and monitor CAPA effectiveness.
  
  

• 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.
• Excellent leadership, communication, documentation, and cross-functional coordination