Specialist - Product Life Cycle

Client of Talentmate

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.

Job Details