Senior Specialist (Product Life Cycle)

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.

Detailed Job Description

• Responsible for Process validation activities for the Oral Solid Dosage form, Oral Liquids and Semi-solids.
• Execute and document process validation activities for OSD, Oral Liquids, and Semi-solid dosage forms.
• Support process development and scale-up activities.
• Participate in the new product introduction (NPI) strategy and ensure validation timelines are in alignment with product launch schedules.
• Interpret process data and statistical evaluations to ensure reproducibility and robustness of manufacturing processes.
• Responsible for the cleaning validation activities for the Oral Solid Dosage form, Oral Liquids, and Semi-solids.
• Plan and execute cleaning validation and verification protocols for equipment used in manufacturing of OSD, liquids, and semi-solid products.
• Ensure sampling methods, swab/rinse techniques, and hold time studies are performed as per current regulatory expectations.
• Identify worst-case product and equipment selection, carry out risk assessments and establish acceptance criteria for residue limits.
• Involved in the strategy of new product launch and ensure that validation deliverables are well aligned with the management timeline.
• Shall be familiar with Wet granulation, tablet press, Coating, Blistering process, Bulk Manufacturing of Orals liquids and semi solids in pharmaceutical industries.:
  
  

Technical Familiarity

• Possess sound knowledge of unit operations including wet granulation, tablet compression, film coating, and blister packaging.
• Ensure understanding of equipment and manufacturing techniques specific to dosage form handling.
  
  

Core Competency

• In terms of competency, you are highly result-oriented with an intense sense of accountability & ownership.
• High compliance adherence, having strong diligence, initiative-taking, and flexibility.
• Excellent communication, interpersonal, and collaboration skills.
• Having a demonstrated skill in leadership and people management
• Motivated, organized, focused & overall compliance.
• Must be able to manage tasks, plan workload effectively, prioritize, and easily adapt to changing situations.
• Ability to understand new learnings and implant them in the workplace.
  
  

Qualification/Functional Knowledge

• Bachelor of pharmacy/Science with minimum work experience of 7-8 years.
• Well experience on SFDA, WHO, EU & USFDA audit exposure.
• Good Computer knowledge and knowledge of QMS system “Agile, Track wise, Amplelogic.”
• Proficient in English.
• Demonstrated solid experience in problem-solving and team management.
• Good Knowledge and command of cGMP
• Risk Assessment knowledge.
  
  

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.