Specialist - Product Lifecycle

Julphar; Ras Al Khaimah; On-site; AED 20,000 - 30,000; Full time

Job summary

A leading pharmaceutical company in Ras Al Khaimah is seeking a Validation Specialist to prepare and oversee validation documentation for sterile facilities. The ideal candidate has a Bachelor's degree in Pharmacy or Science and 3–5 years of relevant experience, as well as a strong knowledge of QMS systems and regulatory audits. This role offers an opportunity to enhance processes and ensure compliance in a dynamic environment.

Qualifications

• 3–5 years of relevant experience in qualification and validation within pharma/biotech.
• Hands-on with regulatory audits (SFDA, WHO, EU, USFDA).
• Strong knowledge of QMS systems.

Responsibilities

• Prepare and oversee validation documentation for Sterile Facilities.
• Conduct process validation for various dosage forms.
• Lead the visual inspection qualification process.

Skills

Results orientation

Communication skills

Problem-solving skills

Technical expertise

Adaptability

Education

Bachelor's degree in Pharmacy or Science

Tools

Agile

Veeva Vault

TrackWise

AmpleLogic

Job description

Overview

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.

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

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.

Core Competencies

• 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.

Qualification & Functional Knowledge

• 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.