Job Ref. ID:
Senior Research Scientist
Research & Development - FND
UNITED ARAB EMIRATES
UAE (RAK head office)
Senior Research Scientist
Full Time Employment (Un-limited Contract)
The role holder is responsible to adhere with the cGMP principles and maintain them in an effective manner. Ensure hundred percent in compliance with all applicable regulations, work performed in area of responsibility is conducted in right manner.
Responsible to design and Development of Generic Pharmaceutical Product in line with QbD approaches, elaboration of manufacturing methods, optimization of the formula and fixing the new product development plan and generate registration documents for submission. Investigate the product development issues and find the solution with scientific manner. As well as responsible for execution of RND experiments/Trials, exhibit/submission batches
Key responsibilities & Accountability:
• Responsible to adhere with the cGMP principles and to maintain them in an effective manner, ensure hundred percent in compliance with all applicable regulations, work performed in area of responsibility is conducted in right manner.
• Design and Development of Generic Pharmaceutical Product in line with QbD approaches, elaboration of manufacturing methods, optimization of the formula and fixing the new product development plan and generate registration documents for submission.
• Investigate the product development issues and find the solution with scientific manner.
• Design and perform experiments for the new product development of various dosage forms as per requirements
• Identify of Critical Quality Attributes(CQA), Critical Material Attributes(CMA) and Critical Process Parameters(CPP).
• Responsible to issue Design of experiments (DOE), Product Remediation plan and assessment.
• Generate and evaluate of Product Development Report as per ICH guidelines.
• Attend to execute the manufacturing of Exhibit batches with necessary documentation.
• Design protocol for new product formulations and organize the resources for continued research.
• Initiate and issue the registration documents related to new product submission and generate documents for the product under notification or variation submission.
• Participate in product monitoring of process optimization and product problem resolution
• Coordinate with cross-functional departments in planning and execution of activities related to product development.
• Monitor and review the R&D formulation lab related relevant SOP’s, CAPA, Change control and ensure the GLP and GDP compliance.
• 4 years Bachelor’s degree in in Pharmacy or related Sciences.
• Master degree in Pharmacy is recommended.
• At least 6-8 years’ experience in the Product Development/Research and Development from a Pharmaceutical field.
• In terms of competency you are highly result oriented with strong sense of accountability & ownership.
• High on compliance adherence, having strong eye for process details.
• Strong attention to details and should be Proactive in approach must have a solution centric mind to understand issues and solve them within a stipulated time frame, ability to understand new issues quickly and make scientific decisions.
• You must have excellent understanding of Pharmaceutical Business with strong analytical skills.
• Strong communication, interpersonal, decision skills required
• Motivated and highly organized professional and should be able to juggle competing priorities.
• Ability to multitask and easily adapt in a fast-paced environment.
• Ability to work under pressure, plan personal workload effectively and delegate.
• Fluent in English (communicating, writing and speaking).
• Proficient in MS Office (MS Excel and MS Word, etc.).
• Skilled in Science concept - Using scientific rules and methods to solve problems.
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