Executive- QA

Title of Associate: - EXECUTIVE (QA)

JOB SUMMARY: -

Perform In-process Quality of manufacturing process and other support functions including sub-contractors and

reporting with respect to Customer requirement and Regulatory guidelines.

REPORTING: -

Reports to Manager QA

ESSENTIAL DUTIES: -

Administration/Internal Communications:

 Responsible for forecasting monthly and yearly requirements of QAD.

 Responsible for providing support to Global Quality projects

Other Duties And Responsibilities

 Responsible for In-process Quality audits at Manufacturing, Utility, warehouse, subcontractors etc.

 Responsible for Non conformance related activities and product disposition.

 Responsible for information on Risk Analysis up-dation required when any change is seen at

process.

 Responsible for the disposition activities related to NC’s in co-ordination with process owners.

 Responsible for data compilation for Post Market surveillance studies.

 Responsible for reporting, trending.

 Responsible for identifying critical issues at Process, support analysis (using Quality tools) with

process owners to arrive at the Root cause and CA.

 Responsible for ensuring GMP requirements are in place during internal audits.

 Responsible for monitoring process sample testing at each stage of Manufacturing.

 Responsible for the identification and preparation of Quality related procedures.

MINIMUM QUALIFICATION REQUIREMENTS: -

Education:

Bachelor’s in Engineering/Pharmacy.

Job Description

The above statements are intended to describe the general nature of level of work being performed by people assigned to this classification. They

are not to be construed as an exhaustive list of all responsibilities duties, and skills required of associates so classified. All associates may be required

to perform duties outside of their normal responsibilities.

Experience:

NA.

 Technical Knowledge and Skills

 Knowledge on using QC Tools & Root Cause Analysis methodology

 Knowledge on performing pFMEA.

 Able to understand and identify key objectives across the business.

 Able to deal with multiple issues, tasks and priorities concurrently

Additional Requirements

 Have strong communication skills complimented with right technical skills to drive meaningful

discussions.

Terumo BCT's Core competencies

 Integrity – Responsible for life and health, should have that sense of mission

 Quality – Responsible for Safety and quality at all stages of manufacturing should have a Gemba

perspective

 Creativity- Capable for taking up challenges for the future and work with passion.

Certificates, Licenses, Registrations:

PHYSICAL & TRAVEL REQUIREMENTS: -

 Need to travel to across INDIA based on the requirement