BioTalent · 1 day ago
Auditor
BioTalent is seeking two experienced GMP Auditors to conduct mock regulatory inspections for an oral solid dosage manufacturing site. Each auditor must have direct, hands-on experience auditing against specific regulatory frameworks, particularly Australian TGA and Russian Health Authority regulations.
Responsibilities
Conduct mock regulatory inspections simulating health authority audits
Perform audits aligned with Australian TGA GMP requirements
Perform audits aligned with Russian Health Authority GMP standards
Focus on oral solid dosage (tablet) manufacturing processes
Qualification
Required
Proven, hands-on experience conducting GMP audits specifically against Australian Therapeutic Goods Administration (TGA) regulations
Proven, hands-on experience conducting GMP audits specifically against Russian Health Authority regulatory requirements
Experience performing regulatory-style inspections or mock inspections
Strong understanding of GMP requirements for oral solid dosage forms (tablets)
General GMP auditing experience alone is not sufficient
CVs must clearly demonstrate audits conducted specifically against TGA or Russian Health Authority frameworks
Availability to travel internationally is required
Preferred
1x Auditor with Australian TGA GMP expertise
1x Auditor with Russian Health Authority GMP expertise
Auditors based in Australia or Russia are preferred, but candidates from other locations will be considered
Company
BioTalent
BioTalent is life sciences recruitment agency with international reach and unrivalled knowledge & expertise.
Funding
Current Stage
Growth StageCompany data provided by crunchbase