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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Expertise in conducting Good Manufacturing Practice (GMP) audits and developing quality assurance plans, with a strong focus on regulatory compliance and effective communication with stakeholders. Proven ability to prepare detailed audit reports and provide corrective action support.
Highest-signal resume keywords
GMP Auditing ExperienceQuality Assurance Plans DevelopmentRegulatory Compliance (FDA, EMA)Analytical Problem-Solving SkillsB2 Level English Communication
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Good Manufacturing Practice (GMP)Audit Report WritingCorrective Action PlansAudit Programs DevelopmentRegulatory Agency Expectations
Soft Skills
Interpersonal SkillsClient Interaction SkillsCollaboration SkillsCommunication SkillsAnalytical Skills
Certifications & Qualifications
Registration in Advarra's Consultant Network
About the role
Key responsibilities & impact- Conduct Good Manufacturing Practice (GMP) audits, including planning, agenda preparation, physical or remote auditing, and report writing
- Evaluate CROs and vendor compliance or qualification
- Prepare comprehensive audit reports detailing findings and root causes
- Provide written audit reports in English
- Provide corrective action support when required
- Present findings to QA leadership and stakeholders when required
- Work collaboratively with clients to ensure quality standards
Requirements
What you’ll need- Minimum 10+ years of Quality Assurance and/or Good Manufacturing Practice (GMP) experience
- Minimum 5+ years of Good Manufacturing Practice (GMP) auditing experience
- Demonstrated experience with regulatory agency expectations (e.g., FDA, EMA) and audit readiness activities
- Demonstrated experience developing and implementing quality assurance plans, audit programs, and corrective action plans
- B2 level in English communication, verbal and written
- Bachelor's degree
- Strong interpersonal and client interaction skills
- Excellent analytical, problem-solving, communication, and report-writing skills
- Ability to work collaboratively across departments and interact with internal and external stakeholders
- Registration in Advarra's consultant network is required to be considered
Benefits
Comp & perks- Inclusive and collaborative work environment
- Respect for diverse perspectives
- Opportunity to make a meaningful impact advancing clinical research
- Consultant network affiliation
