Manager - CQA

Job Description

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.
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.

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.

Work Experience

12-18 years in teh area of remediation, quality assurace, compliance, audit management, etc. 

Education

Competencies