Job Ref. ID:
Formulator Assistant Officer
Research & Development
UNITED ARAB EMIRATES
UAE (RAK head office)
Research & Development - Formulation Assistant Officer
Full Time Employment (Un-limited Contract)
The Pharmaceutical R&D department develops new dosage forms and takes care of process development and scale-up activities. Formulator Officer or Sr. Officer position will be responsible for pharmaceutical product development and associated activities in R&D. Handles and monitors the formulation development activities Oral solid dosage formulations (OSD). Also he will be responsible for process optimization, scale-up and tech transfer of new products, supports to Regulatory department for new products dossier submission to various markets. Actively involved in the validation and qualification of the facility and documentations, and other tasks assigned.
Key responsibilities & Accountability:
carrying out the literature search on APIs, patents, excipients, technologies for the development of solids (Tablets: IR, DR & ER dosage forms & capsules: powder and pellets filled). Responsible for independently carry out the Formulation R&D and scale up activities. Preparation and review of stability, scale up, process validation protocols and reports, specifications (raw material, packaging material & product) etc. Compilation, review and interpretation of product development results, drawing conclusions and way forward in formulation development. Compilation of hold time study reports, product development reports, quality overall summary (QoS), QbR for dossier preparation. Coordination with cross functional teams for the timely completion of assigned activities.
Needs to have a Master's degree / ph.D or equivalent in pharmaceutical science studies.
Experience in liquid oral and semisolid dosage formulation is an additional. Experience in handling equipment like RMG, Fluid bed driers & granulators, size reduction mills, blenders, compression, coating and capsule filling machines.
- Specialized Knowledge and Skills:
Sufficient knowledge of regulatory guidelines (EU, US & Emerging Markets) and requirements, Good Documentation Practices. Needs to process in-depth knowledge about the basic and advanced concepts that are related to pharmaceutical development studies and process optimization. Should be familiar with the regulatory requirements/guidelines and QbD (Quality by Design). Excellent organizational and planning abilities. Excellent communication and report writing skills. Proactive, self-starter
AccountabilityAnalytical ThinkingCommunicating in WritingCommunicating OrallyContinual ImprovementContinual LearningEstablishing FocusExercising Self-Control/Being ResilientFacilitationFlexibilityGetting ResultsInitiativeInnovation
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