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Title:  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.

 

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

 

 

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