Company Overview
Role Purpose
Academic Stream
Work experience (in months)
Job Responsibility and key Decisions
Interaction with Production, Research and Development, Quality Assurance, and other cross functional teams for smooth running of QC laboratory
Interaction with Regulatory department in review of dossier and addressing any MOHcustomer queries.
Interaction with EHS department for laboratory and personnel safety.
Job Responsibility Key Decisions
cGMP Current Good Manufacturing Practice and cGLP Current Good Laboratory Practice regulations and compliance.
Ensuring an effective quality system is in place, adequately resourced and the roles, responsibilities and authorities are defined, communicated, and implemented throughout the organization.
Corrective action preventive action as and where applicable.
Approve or reject all Drug substance and raw materials
Budgeting for Quality control department.
Coordinate for conducting internal audits.
Handling complaints relating to quality of the product Customer as well as regulatory bodies.
Audits Internal auditor and auditee for customerregulatoryinternal audit.
Production process control in coordination with production.
Evaluation of all nonconfirming products and out of specification reports.
Identification of training needs and ensure effective implementation of training in quality control.
Implementation and adherence to laboratory safety.
Process validation review of protocol and report
Cleaning validation review of protocol and report
Recruitment of QC personnel
Review of OOS investigation
Identification of training needs and ensure effective implementation of training in quality control.
Analytical Method Validations and method transfers review of protocol and report.
Analytical method optimization wherever applicable.
Review of OOS investigation
Ensuring effectiveness of the quality management system by review of all the Quality related documents like standard operating procedures, instrument operating procedures, general analytical methods, raw material in processfinished product specifications, incidents, deviations, Change controletc.
Review of Stability data.
Addressing customer queries through meetings, telecons and email communications.
Ensuring effective implementation of EHS management system in the organization.
Propagating EHS Management system awareness to all the personnel and report the recommendations to the management.
Reviewing the progress of EHS implementation.
Report compliance adherence to the EHS management system.
To communicate relevant EHS issues to concerned personnel.
To interact with employees regularly to understand the perceptions and opinions on EHS related matters.
To follow the established procedures and policies of the company pertaining to EHS and report on the performance to the management.
To involve in management review meetings to identify opportunities for continual improvement of product, process, and system.
