Senior Specialist (Product Life Cycle)

Julphar; Ras Al Khaimah; On-site; AED 120,000 - 200,000; Full time

Job summary

A leading company in pharmaceutical manufacturing seeks a Process Validation Specialist to oversee validation activities for various dosage forms. The ideal candidate will hold a Bachelor’s degree in pharmacy or science, have 7-8 years of experience, and possess strong problem-solving and team management skills. This role is vital in ensuring compliance with regulatory standards and supporting new product introductions, contributing to positive patient outcomes and company success.

Qualifications

• 7-8 years of experience in process validation activities.
• Experience with SFDA, WHO, EU, and USFDA audits.
• Proficient in English and familiarity with QMS tools.

Responsibilities

• Responsible for process validation activities for OSD, liquids, and semi-solids.
• Execute and document validation activities, ensuring regulatory compliance.
• Participate in new product introduction strategies and risk assessments.

Skills

Results-oriented

Excellent communication

Problem-solving

Team management

Education

Bachelor's degree in pharmacy or science

Tools

Agile

TrackWise

AmpleLogic

Job description

At Julphar, we are on a journey of culture transformation, and 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—along 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 the dedication of our employees.

Detailed Job Description

1. Responsible for process validation activities for Oral Solid Dosage (OSD), Oral Liquids, and Semi-solids.
2. Execute and document process validation activities for these dosage forms.
3. Support process development and scale-up activities.
4. Participate in the new product introduction (NPI) strategy, ensuring validation timelines align with product launch schedules.
5. Interpret process data and perform statistical evaluations to ensure reproducibility and robustness of manufacturing processes.
6. Responsible for cleaning validation activities for OSD, liquids, and semi-solids.
7. Plan and execute cleaning validation and verification protocols for manufacturing equipment.
8. Ensure sampling methods, swab/rinse techniques, and hold time studies meet current regulatory standards.
9. Identify worst-case products and equipment, conduct risk assessments, and establish acceptance criteria for residue limits.
10. Involved in new product launch strategies, ensuring validation deliverables are aligned with management timelines.
11. Familiarity with wet granulation, tablet pressing, coating, blistering, and bulk manufacturing of oral liquids and semi-solids.

Technical Familiarity

• Knowledge of unit operations including wet granulation, tablet compression, film coating, and blister packaging.
• Understanding of equipment and manufacturing techniques specific to dosage forms.

Core Competencies

• Results-oriented with a strong sense of accountability and ownership.
• High compliance adherence, diligence, initiative, and flexibility.
• Excellent communication, interpersonal, and collaboration skills.
• Leadership and people management skills.
• Motivated, organized, focused, and compliant.
• Ability to manage tasks, plan workload, prioritize, and adapt to changes.
• Quick learner and ability to implement new knowledge in the workplace.

Qualifications and Functional Knowledge

• Bachelor’s degree in pharmacy or science with 7-8 years of experience.
• Experience with SFDA, WHO, EU, and USFDA audits.
• Proficiency with computer systems and QMS tools such as Agile, TrackWise, AmpleLogic.
• Proficient in English.
• Strong problem-solving and team management skills.
• Good knowledge of cGMP and risk assessment.

We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to learn more about us and our journey.