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
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