Specialist - Product Lifecycle

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.

Main Responsibilities

• Prepare, review, and oversee process and cleaning validation documentation and execution activities for Sterile Facilities, including Liquid Injectables, Lyophilized products, and Sterile Powder Filling.
• Conduct process validation for various dosage forms such as Oral Solid Dosage (Tablets, Capsules, PPS), Oral Liquids (Syrups, Suspensions, Oral Drops), and Semi-Solids (Ointments, Creams, Suppositories).
• Manage process validation activities for API biological drug substances and sterile products.
• Demonstrate familiarity with filter validation requirements in sterile areas.
• Design and execute Aseptic Process Simulation (APS) studies, including preparation of related protocols and reports.
• Lead the visual inspection qualification process.
• Manage shipping validation activities for cold chain products.
• Oversee cleaning validation activities, including dirty equipment hold-time studies.
• Review and support Change Controls, CAPAs, and Deviations associated with qualification and validation activities.
• Act as Quality General in EQMS to complete actions related to qualification and validation.
• Monitor and verify CAPA effectiveness related to validation activities.
  
  

• Strong results orientation with a high level of accountability and ownership.
• Ability to prioritize, multitask, and perform effectively under pressure to meet deadlines.
• Excellent communication, interpersonal, and collaboration skills.
• Highly disciplined, organized, and self-motivated to learn and implement new practices.
• Proven technical expertise in qualification and validation within sterile and biotech facilities.
• Strong implementation skills with adaptability to changing business requirements.
• Ability to work effectively in cross-functional environments, collaborating with internal and external stakeholders.
• Strong capability to communicate technical, scientific, and regulatory information clearly—both verbally and in writing.
  
  

• Education: Bachelor’s degree in Pharmacy or Science.
• Experience: Minimum 3–5 years of relevant experience in qualification and validation within the pharmaceutical/biotech industry.
• Hands-on experience with regulatory audits (SFDA, WHO, EU, USFDA).
• Strong working knowledge of QMS systems such as Agile, Veeva Vault, TrackWise, and AmpleLogic.
• Excellent computer proficiency and command of English (written and spoken).
• Demonstrated problem-solving and team coordination skills.
• Solid understanding of cGMP principles and Risk Assessment methodologies.