Process Lead - Product Life Cycle (Sterile API Drug Substance)

Julphar; Ras Al Khaimah; On-site; AED 80,000 - 120,000; Full time

Job summary

A leading pharmaceutical company seeks a Validation Specialist in Ras Al Khaimah to enhance their processes in sterile and biotech facilities. The role demands strong expertise in validation protocols, regulatory compliance, and the ability to work in cross-functional teams to effectively ensure product quality and safety.

Qualifications

• 8–10 years of experience in pharmaceutical validation, especially with solid oral dosage forms.
• Proven expertise in process validation, cleaning validation, and hold time studies.
• Strong command of EU GMP, FDA, WHO, and data integrity.

Responsibilities

• Responsible for validation documents and oversight for Sterile Facilities.
• Lead packaging validation for sterile and biotech dosage forms.
• Conduct risk-based cross-contamination assessments.

Skills

Communication

Collaboration

Accountability

Education

Bachelor’s or master’s degree in pharmacy, Chemistry, Biotechnology

Job 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 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