Audit manager




Job Title:
Audit and Inception Manager

Candidates Specification:

GXP Quality control and GCP Audit experience

Experience in PV

Educational Qualification: University/college degree BA/BS (life science preferred) or equivalent

Salary best in industry

Job Description

Must have 4+ years of experience in GXP Quality Control and GCP Audit Experience

Responsible for supporting internal external regional and global QA audits per Standard Operating

Procedures and Master Audit Plan assuring that audited systems processes and their outcomes

comply with applicable international and national regulations and guidelines and fulfil client

requirements.

Lead audit teams in the conduct reporting and follow up of regional and global QA audits ensuring

compliance to applicable SOPs Master Audit Plan and within specified timeframes and quality

standards

Provide suitable recommendations for audit observations; ensures auditees deliver appropriate

CAPAs and follows them up through closure. Escalates as appropriate were resolution

of audit findings is inadequate

Proactively identifies and leads process improvement activities/SOP creation and revisions

Able to host client audits and able to support regulatory inspections

Leads and/or participates in special projects

Thorough knowledge understanding and experience applying ICH Guidelines GCPs including

applicable regulatory requirements for the conduct of clinical development programs

Knowledge of the drug development process

Responsible for supporting internal external regional and global QA audits per Standard Operating

Skills: Gxp, QA Audit, Capa, Cro

Experience: 3.00-8.00 Years