GlaxoSmithKline
Internal Auditor
GlaxoSmithKline, Rockville, Maryland, us, 20849
Site Name:
USA - Maryland - RockvillePosted Date:
Aug 29 2024GSK is currently looking for an Internal Auditor to join our team in Rockville, MD. In this role, you’ll manage the site Management Monitoring, Internal Audit (Internal Business Management) and Site Managed External Supplier Audit Programs. Provide guidance to the site in the area of cGMP compliance. Handle the coordination of CAPAs (CAs) within MERP and VQMS for audit observations.Key Responsibilities:Acts as a Certified Lead Auditor during Rockville internal and external supplier audits.Generates and obtains approval for audit plan on an annual basis. Holds meetings as required to review audit plan, as well as holding meetings to review and explain audit findings with designated members of management.Issues internal and external supplier audit reports using existing format. Reviews responses for adequacy and communicates discrepancies with responses to owners. Assists owners as required with responses to audit observations.Ensures all internal/supplier audits are responded to in a timely fashion as defined in the audit report, and tracks progress to ensure audit commitment dates are met on time. Generates and publishes monthly report for outstanding internal/supplier audit commitments. Performs follow-up for responses to ensure corrective actions as committed are implemented.Assists in the preparation for and participation in regulatory agency inspections, corporate and customer audits. Performs audit observation follow-up for global quality assurance audits and regulatory inspections as requested.Manages the site Management Monitoring Program.Acts as a student of current regulatory expectations and provides consultation to customers on interpretation of regulation and guidance published by regulatory agencies, industry and GSK.Collect and compile data for Site Quality metrics and quality related trending within required timeframes.Why you?
Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:BA/BS Degree5+ years of GMP experienceMust have audit experiencePreferred Qualifications:If you have the following characteristics, it would be a plus:Thorough technical and regulatory knowledge of current pharmaceutical manufacturing techniques and the applicable current regulatory and GSK requirements.Developed auditing skills: developing and executing an audit plan, preparing and using checklists, following-up, documenting findings, etc.Certification as a Quality Auditor is desirable.Excellent verbal / written communication and interpersonal skills: respect for people, sensitivity to cultural differences, active listening, succinct writing, decision-making ability, objectivity, and assertiveness.Solid ethics and Integrity: confidentiality, impartiality, independent, straightforward, and sensitivity to problems.
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USA - Maryland - RockvillePosted Date:
Aug 29 2024GSK is currently looking for an Internal Auditor to join our team in Rockville, MD. In this role, you’ll manage the site Management Monitoring, Internal Audit (Internal Business Management) and Site Managed External Supplier Audit Programs. Provide guidance to the site in the area of cGMP compliance. Handle the coordination of CAPAs (CAs) within MERP and VQMS for audit observations.Key Responsibilities:Acts as a Certified Lead Auditor during Rockville internal and external supplier audits.Generates and obtains approval for audit plan on an annual basis. Holds meetings as required to review audit plan, as well as holding meetings to review and explain audit findings with designated members of management.Issues internal and external supplier audit reports using existing format. Reviews responses for adequacy and communicates discrepancies with responses to owners. Assists owners as required with responses to audit observations.Ensures all internal/supplier audits are responded to in a timely fashion as defined in the audit report, and tracks progress to ensure audit commitment dates are met on time. Generates and publishes monthly report for outstanding internal/supplier audit commitments. Performs follow-up for responses to ensure corrective actions as committed are implemented.Assists in the preparation for and participation in regulatory agency inspections, corporate and customer audits. Performs audit observation follow-up for global quality assurance audits and regulatory inspections as requested.Manages the site Management Monitoring Program.Acts as a student of current regulatory expectations and provides consultation to customers on interpretation of regulation and guidance published by regulatory agencies, industry and GSK.Collect and compile data for Site Quality metrics and quality related trending within required timeframes.Why you?
Basic Qualifications:We are looking for professionals with these required skills to achieve our goals:BA/BS Degree5+ years of GMP experienceMust have audit experiencePreferred Qualifications:If you have the following characteristics, it would be a plus:Thorough technical and regulatory knowledge of current pharmaceutical manufacturing techniques and the applicable current regulatory and GSK requirements.Developed auditing skills: developing and executing an audit plan, preparing and using checklists, following-up, documenting findings, etc.Certification as a Quality Auditor is desirable.Excellent verbal / written communication and interpersonal skills: respect for people, sensitivity to cultural differences, active listening, succinct writing, decision-making ability, objectivity, and assertiveness.Solid ethics and Integrity: confidentiality, impartiality, independent, straightforward, and sensitivity to problems.
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