Overview
Formulator Jobs in Amman, Amman, Jordan at MS PHARMA
Title: Formulator
Company: MS PHARMA
Location: Amman, Amman, Jordan
Description
Develop products as per the required standards and specification while meeting project timelines and set budget. Development tasks include literature review, preformulation, formulation and scale up and support analytical research activities according to the direction of the supervisor and the written SOPs.
Executive & Technical Duties
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 the 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 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.
Support manufacturing activities of the first 3 process validation batches at commercial scale post approval.
Follow & implement Good Laboratory Practice GLP, Good Manufacturing practice GMP and Standard Operating Procedures SOPs when performing job related tasks.
Ensure compliance with relevant national and international health, safety and environmental laws and policies as well as maintain the records and reports of HSE aspects.
Perform other duties or tasks as assigned by the direct supervisor.
Education
B.Sc. degree in Pharmacy
Experience
0-2 years of relevant experience in pharmaceutical formulation
Language
Good written, read and spoken Arabic and English Languages
Professional Knowledge
Knowledge in systems such as ICH, GMP, GLP, GDP, WHO
International Regulations
Ministry of Health Regulations
Knowledge in Registration Requirements
Pharmacopeia
Formulation development
Process development
Clinical studies protocols & requirements
Stability protocols design
Validation protocols design