Catalent
pharmaceutical and biotechnology
PrincipalQualityAssociate,ClientAudits
“Principal Quality Associate, Client Audits at Catalent. Skills: Quality Assurance, auditing, cGMPs, client audits, regulatory inspections. perform and facilitate system-based audits and risk assessments for client audits, regulatory inspections and internal quality systems. support non-commercial and commercial client audits and regulatory inspections”
What You'll Achieve.
Prepare reports on KPIs and CAPA status based on the overall achievements of the audit program; Ensure compliance to all regulatory, compendial, internal and client-specific requirements
Industry & Context.
risk assessments
sit, stand, walk regularly, occasionally lift up to 15 pounds, Some exposure to hazardous chemicals and other active chemical ingredients, 100% based on-site in Greenville, NC
What They're Looking For.
Must Have
Bachelor’s degree with at least six years of Quality Assurance experience, five years of which must be in an OR an Associate degree with at least seven years of Quality Assurance experience, six years of which must be in an auditing role, Experience with client and/or regulatory authority verbal and written interactions is a must, Demonstrated knowledge of regulations and guidelines associated with cGMPs for pharmaceutical and biotechnology industries, Knowledge of manufacturing and laboratory processes
Nice to Have
ASQ CQA certification
What You'll Do.
perform and facilitate system-based audits and risk assessments for client audits
regulatory inspections and internal quality systems
support non-commercial and commercial client audits and regulatory inspections
coordinate and conduct client record findings to prepare responses
Participate in Regulatory Inspections as required
Assure the competence of client audit team members including subject matter experts
select appropriate audit support teams and assign roles and responsibilities
and train staff including subject matter experts to conduct or assist with audits
Respond to questions and information requests from clients and regulatory authorities
complete questionnaires
track client quality agreement status and maintain audit program records
Initiate CAPA in response to client and regulatory audit observations and conduct periodic follow-up with responsible draft the overall audit response for review by management
Act as a company auditing resources when required
Monitor the performance and effectiveness of the quality support activities for client services
Prepare reports on KPIs and CAPA status based on the overall achievements of the audit program
Ensure compliance to all regulatory
internal and client-specific requirements
How You'll Work.
Team & Collaboration
Assure the competence of client audit team members including subject matter experts, select appropriate audit support teams and assign roles and responsibilities, and train staff including subject matter experts to conduct or assist with audits
Communication Scope
client and/or regulatory authority verbal and written interactions
Process & Methodology
Plan, schedule, coordinate
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