Executive - Manufacturing Science and Technology (MST)

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

Responsibilities:

Analytical method validation:

Analytical method DevelopmentAnalytical method transfer, Analytical method validation

CMC Activity

Sampling & testing of Process water, Raw materials, Intermediates, APIs, stability samples, hold time study samples & Cleaning validation samplesSending samples to third party/customer, Preparation and approval of CoA, Generation and archival of GMP documentsPreparation of system & operational SOPs using eDMSMaintaining inventory of laboratory reagents and chemicalsProviding analytical support to pilot plant in case of deviation investigationCo-ordination with pilot plant & PRD to provide analytical supportInvestigation in case of OOS/OOT, laboratory incidence, deviation & customer complaintImpurity & reference standard qualification, Management of change control, OOS/OOT, deviation

CGMP

Compliance to current GMP guidelines, Follow ALCOA principal maintaining GMP dataCompliance to local and international norms (Quality/HSE)Knowledge of change control and deviation managementRegulatory complianceRegular Pharmacopoeia and regulatory requirement reviewTraining 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 instrumentCo-ordination with service provider for repairing and preventive maintenanceQualification of laboratory instrumentsManagement of logbooks

Other

Complying to HSE RequirementsIdentifying 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.

Requirements

• GMP & 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