Job Ref. ID:
Formulation Senior Officer
Research & Development
UNITED ARAB EMIRATES
UAE (RAK head office)
Research & Development - Formulation Senior Officer
Full Time Employment (Un-limited Contract)
The Senior Officer will adhere with the cGMP principles and maintain them in effective manner. He will perform job related to Formulation and Development of Biosimilar & Injectable products, Scale-up, Technology Transfer and its documentation.
Key responsibilities & Accountability:
Plan, design and performed experiments for the development of biosimilar product as per regulatory requirement after thorough literature survey. Develop well-conceived plan, protocol for designing new product formulations and organize the resources for continued research till scale-up. Involved with Manager in formula optimizing for stability purposes, production and documentation and set specifications at the end of product's shelf life. Prepare, review and takes responsibility on documentation to maintain and assure status of compliance. Prepare Registration dossier of products for submission, support CTD and dossiers compilation. Participate and lead critical investigations in trouble shooting problematic formulations working in hand with R&D Manager/Director and conclude with proven resolutions. Develop methods of manufacture for all new and reformulated products for complying pharmacopoeia / FP specifications. Supervise the manufacture of pilot batches and maintain record. Assist and support manufacturing of scale-up batches, documentation and technology transfer of products and processes to production. Support RA for regulatory query. Manufactures and arranges samples for registration, stability and BE studies. Involvement in better housekeeping rules, safety affairs and GLP and SOP compilation. Arrange reference samples for future study purposes. Takes part in training and staff monthly / and when required. Maintain equipment logbooks. Preparation, revision and training of SOP. Regulatory audit compliance. Follow instructions of R&D Manager / R&D Director.
Graduate of bachelor's degree either in Pharmacy, Chemistry, Chemical Physics, or any related medical field. Master's degree either in Pharmacy, Chemistry, Chemical Physics, or any related medical field is an advantage.
At least 6-7 years' experience in the Product Development / Research and Development from a Pharmaceutical field.
AccountabilityAnalytical ThinkingCommunicating in WritingCommunicating OrallyContinual ImprovementContinual LearningEstablishing FocusExercising Self-Control/Being ResilientFlexibilityGetting ResultsInitiativeInnovationInterpersonal Skills
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