Job Description

Position Title: Executive : Manufacturing Science and Technology (MST)
Qualification and Experience:
POST GRADUATE IN CHEMISTRY/PHARMACY Experience: 0-7 years of Experience as an analyst/Development technologist in the Pharmaceuticals / API industry. GMP & GLP knowledge
Job overview:
Providing analytical support for Chemistry activities ensuring compliance to regulatory, group directives, quality requirements, safety standards to fulfill the organization's objective, living Group's Values and Code of Ethics
Responsibilities:
Analytical method validation:
Analytical method Development
Analytical method transfer, Analytical method validation
CMC activity:
Sampling & testing of Process water, Raw materials, Intermediates, APIs, stability samples, hold time study samples & Cleaning validation samples
Sending samples to third party/customer, Preparation and approval of CoA, Generation and archival of GMP documents
Preparation of system & operational SOPs using eDMS
Maintaining inventory of laboratory reagents and chemicals
Providing analytical support to pilot plant in case of deviation investigation
Co-ordination with pilot plant & PRD to provide analytical support
Investigation in case of OOS/OOT, laboratory incidence, deviation & customer complaint
Impurity & reference standard qualification, Management of change control, OOS/OOT, deviation
cGMP:
Compliance to current GMP guidelines, Follow ALCOA principal maintaining GMP data
Compliance to local and international norms (Quality/HSE)
Knowledge of change control and deviation management
Regulatory compliance
Regular Pharmacopoeia and regulatory requirement review
Training of self on quality and HSE systems.
Instrumentation:
Operation & calibration of HPLC, GC, HSGC, UPLC, UV, FITR, DSC & other laboratory instruments, Trouble shooting for said instrument
Co-ordination with service provider for repairing and preventive maintenance
Qualification of laboratory instruments
Management of logbooks
Other
Complying to HSE Requirements
Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations.
Carrying out any other assignments or projects as per the instruction of the Dept. Head to meet with the organizational objectives and priorities.
RequirementsGMP & GLP knowledge, Good coordination & communication skills. Analytical ability, Knowledge on LIMS & QMS

What makes this position unique?This position will provide good exposure to work in Analytical Method Development and validation, GMP/ GLP environment.

Location Information: Ankleshwar, Gujarat, India