Specialist (Product Life Cycle)
- رأس الخيمة
- دائم
- دوام كامل
- 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.
- 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.
- 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.
- 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.
- 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.