Principal Quality Auditor, GMP Audit

Endo Pharmaceuticals Chestnut Ridge , NY 10977

Posted 2 months ago

Job Summary - a concise overview of the job

Independently performs quality audits of sterile drug product manufacturers, contractors and suppliers that support marketed drug products to ensure products, controls, procedures and processes meet quality standards. Prepares audit reports and communicates findings to external and internal stakeholder. Able to act completely independently as a QA auditor.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Audits, across multiple sites, drug product manufacture, suppliers of API, excipients, packaging components, and firms providing GMP services such as laboratories and others as required.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Compliance Audits

(external)

Independently conducts external audits, acting as Lead Auditor of an audit team, or participating as an external audit team member.

Provide sterile expertise and experience in auditing

Able to perform high profile due diligence audit for corporate management.

Schedules audit activities and develop audit agenda.

Independently performs evaluations of quality systems and practices to identify potential problems such as Non-Conformance to applicable SOPs and Quality Standards (GMP, ICH, ISO, IPEC, etc.), coordinates resolutions, and provides guidance on quality/compliance risk levels.

Prepares audit reports and communicates findings to external and internal stakeholders.

Tracks audit responses and auditee's CAPA until completion and closeout.
80%

Corporate Enterprise Audits

(internal)

Acts as Lead Auditor for the Endo sterile audit team for all internal audits.

Schedules audit activities with the internal site and provide audit agenda.

Performs evaluations of quality systems and practices to identify potential problems such as Non-Conformance to applicable SOPs and quality standards (GMP, ICH, ISO, IPEC, etc.), coordinates resolutions, and provides guidance on quality/compliance risk levels.

Prepares audit reports and communicates findings to internal stakeholders.

Tracks audit responses and auditee's CAPA until completion and closeout.
10%

Regulatory Inspection Support

Provides document support for regulatory audits and mock inspections.

Stays up to date on current FDA and EU sterile manufacturing trends
5%

Compliance Department Support

Leads and/or supports cGMP projects for continuous improvement to ensure compliance with regulations and current industry standards.

Becomes knowledgeable through experience of Endo supply chain. Act as source of information on all Quality issues with Endo Supply chain vendors.

Participates in the development of QA programs, policies, procedures and controls.
5%

Total
100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and certifications required for the job
5-10 years sterile manufacturing experience in either quality or manufacturing (supervisory experience desired). 5-10 years Microbiology laboratory experience also acceptable.

Minimum of a BS degree in Science or Pharmaceutical studies with a minimum of 8 years' experience in a pharmaceutical manufacturing or Quality Assurance environment.

ASQ-CQA or ASQ-CQE certified desired.

Knowledge

Proficiency in a body of information required for the job

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

Possesses a technical and quality background related to sterile pharmaceuticals.

Has solid experience and technical expertise in 4 or more audit areas, such as API, Micro Lab, Sterile drug product, Contract Pkg., Mock PAI, etc.

Has thorough knowledge of current standards and regulations related to pharmaceutical dosage forms/devices, (e.g., cGMP, GLP, ICH guidelines and guidance documents) and how to apply them to products pending release, and marketed products.

Demonstrates the ability to review investigations, change control, analytical data, test reports, batch records and certificates of analysis and other technical documents.

Demonstrates the ability to conduct GMP audits of sterile drug product and/or medical device manufacturers, as well as manufacturers of chemical raw materials and packaging components.

Demonstrates the ability to conduct focused quality incident investigations.

Shows ability to train new auditors.

Skills

&

Abilities

Often referred to as "competencies", leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.

Strong ability with MS Word, Excel, Power Point and Outlook.

Good communication skills - written and verbal.

Physical Requirements

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

Walk across factory / warehouse can climb stairs and ladders.

Travel Domestic and International (approx. 20-30%).

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job.

They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.



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Principal Quality Auditor, GMP Audit

Endo Pharmaceuticals