Deputy General Manager - CQA

Job Description

Responsible for conducting corporate internal audits and review of various quality systems at site in adherence to CGMP, GxP, Data integrity and any other applicable regulatory requirements.
Review the Quality Regulatory Intelligence inputs and ensure its implementation across the network through review of gap assessments and compliance proposals; and verifying compliance actions for their implementation and effectiveness.
Review of regulatory commitments and its compliance
Perform gap assessment against regulatory audit observations, evaluate and co-ordinate with manufacturing sites for implementation of CAPAs.
Responsible for Quality metric data collection along with critical & repeated quality issues, status of quality initiatives/programs to be presented to senior management as part of Global Quality Corporate Steering Committee (GQCSC) meetings.
Impart training on SOPs to site personnel as and when required.
Support for any organizational corporate initiative assigned
Providing support for vendor audits as and when required
Coordinate with sites for evaluation of quality system and procedures as per requirement.
Providing inputs on Corporate Quality SOPs to comply with current regulatory guidance and requirements.
Shall review best procedures/practices followed at each site and inform to other manufacturing sites for implementation of harmonization procedures/practices across all locations.

Work Experience

15-20 years of experience in Quality Management specifically Quality Assurance, Quality Control, Compliance, Auditing etc. Min. 5 years of experience in self inspections and / or auditing

Education

Competencies