Job Description and Requirements
Job Scope :
Develop products as per the required standards and specification while meeting project timelines and set budget. Development tasks include literature review, pre-formulation, formulation and scale up and support analytical research activities according to the direction of the supervisor and the written SOPs.
Job Requirements:
- B.Sc. degree in Pharmacy.
- 0 – 2 years of relevant experience in pharmaceutical formulation.
- Good written, read and spoken Arabic and English Languages.
Duties and Responsibilities (But not limited to):
- Develop new drug products as per the requirements of ICH Q8, Q9 and Q10 and other scientific guidelines where applicable.
- Conduct literature survey/Review.
- Conduct the relevant physical and chemical testing on the formulation trials.
- Prepare small-scale batches to evaluate product stability manufactured using prototype formula.
- Support relevant activities related to stress stability studies. This part is to be done in collaboration with analytical research department.
- Perform different experiments as per the direction of the supervisor to address formula optimization, formula reprocessing and full reformulation experiments for existing commercial products.
- Documentation of all formulation trials and test results using appropriate formats as per the relevant SOPs.
- Prepare a all documents required for submission including pharmaceutical development report, draft of the master drug product formula, Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs).
- Scale up manufacturing process to pilot scale and/or production scale to support development activities and to prepare 3 stability batches to support submission activities as defined by the SOP.
- Implementation of current GLP and current GMP where applicable.
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