Product Development Officer

Responsibilities & Context

To perform physical and chemical tests relevant to product development, analytical method.

Development and validation of new and reformulated existing products.

To perform physical and chemical tests required for pre-formulation study by lab batch analysis of new and reformulated existing products.

To perform physical and chemical tests required for stability analysis such as accelerated stability, in use, real time or ongoing study of new and reformulated existing products.

To compile stability data for reformulated existing products based on accelerated stability, in use, real time or ongoing study.

Review & change implement of analytical methods and development procedure considering easiness, minimum consumption of reagent or solvent and reduction of cost. To implement the procedures & Instructions of ISO -9001:2015 & 14001:2015 in own area of activity.

To undertake work related to specification change of development products and perform tests of incoming materials and products.

To ensure product stability by conducting stability studies as per protocol and analyzing data.

To perform in use stability by conducting stability studies as per protocol and analyzing data.

To ensure compliance of GLP at all stages of testing of products under product development program.

To perform physical and chemical tests of Innovator/leader products along with own products to compare during stability.

To prepare product manual (if required, in case of method, & product specification change) before technology transfer to validation department.

To perform works relevant to preparation and standardization of chemical reagents & working standard.

To implement GLP and ensure safe storage, distribution & disposition of reagents and chemicals.

Maintain records relevant to analysis, testing, batch processing etc. under product development.

Any other task assigned by GM, QA/Head, Product Development/Immediate Supervisor, PD.

Education

Master of Pharmacy (M.Pharm) in Pharmacy, Master of Science (MSc) in Chemistry, Master of Science (MSc) in Biochemistry, Master of Science (MSc) in Applied Chemistry

Experience

1 to 2 years

The applicants should have experience in the following business area(s):

Pharmaceutical/Medicine Companies

Additional Requirements

Age at most 30 years

Should have updated knowledge on API, Pre-Formulation study, Good documentation, Process validation, Cleaning validation, Method validation, Deviation management, Change control, Stability study, Impurity test of RM & FG, ICH guidelines relating to new product development & stability studies, etc.

Should have updated knowledge on Formulation development, Pre-Formulation study, Good documentation, Process validation, Cleaning validation, Method validation, Deviation management, Change control, Process control, Stability study, Impurity test of RM & FG, ICH guidelines relating to new product development & stability studies, etc.