QA Auditor Cover Letter

I would like to submit my application for the QA auditor opening. Please accept this letter and the attached resume.

In my previous role, I was responsible for interpretation and guidance for internal and external customers on clinical quality related regulations / guidelines (Food & Drug Adminstration, Inernational Council for Harmonisation, EU, etc.) and company procedures and policies, proactively maintaining cognizance of current Good Clinical Practice standards.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Experience creating training aids, work instructions and technical reports is preferred
• GMP compliance knowledge including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1 and FDA Guidance on Aseptic Processing
• Appraisal delivery
• Knowledge of nuclear and other regulatory quality/QAPM requirements
• See ANSI/ANSN45.2.23-1978 and Procedure EN-QV-117, Attachment 9.2, 'Lead Auditor Qualification / Certification Form'
• Conduct all assigned GMP audits
• Approve Corrective and Preventive Actions which are necessary due to audit findings
• Evaluate and trend audit and inspection findings

I am excited to be applying for the position of QA auditor. Please accept this letter and the attached resume as my interest in this position.

In my previous role, I was responsible for advice and service to all operating departments as to assure compliance with cGMP’s and other regulations.

My experience is an excellent fit for the list of requirements in this job:

• Understand the risk and benefits of findings on the division(s) through engagement with the businesses and/or regions
• Demonstrates high proficiency in selected areas
• Prior quality inspection experience preferred
• Previous management/supervisory experience in these areas operations, engineering, chemistry, radiological protection, training and/or maintenance
• Experience within packaging/food products industry, preferred
• Prior HACCP experience preferred
• Preferred Bioanalytical experience
• Expert in GxPs is desirable

I am excited to be applying for the position of QA auditor. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for advice and knowledge in regard to interpreting Good Manufacturing Practice guidelines and regulations.

Please consider my qualifications and experience:

• Maintain audit data in a related data system (incl
• Exploring potential data integrity concerns during audit
• Identify compliance risks and develop sound rational for observations against current regulatory requirement and standards
• Support training sessions, audit planning and Risk Assessments
• Ensure effective follow-up audits of sites with significant quality and compliance issues
• Conduct Pre-Qualification audits of potential new Suppliers and Contractors
• Keep Senior management aware of emerging Regulatory and GMP trends to help avoid Compliance Risks
• Assist in the establishment and maintenance of effective KPIs to help identify key quality and compliance trends and issues

Please consider me for the QA auditor opportunity. I am including my resume that lists my qualifications and experience.

In the previous role, I was responsible for interpretation of GxP and Pharmacovigilance regulations and company process standards, guidelines, policies and procedures to relevant personnel.

Please consider my experience and qualifications for this position:

• Willing to travel extensively in India and APAC region, and on short term off site as-signments for remediation projects based on business needs
• Experience with MS Dynamics is preferred
• Inspection and / or distribution center experience preferred
• Understand technical decisions that affect product quality
• Identify and communicate compliance issues and risks promptly so that they are understood
• Provide guidance and trains colleagues, provides oversight to junior level auditors
• May assume managerial experience
• Utilizes expertise and audit intelligence during audits

In response to your job posting for QA auditor, I am including this letter and my resume for your review.

Previously, I was responsible for technical expertise in the design, implementation and management of stability studies, including relevant documentation, in line with current regulations, PQS and business needs.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Relevant GxP experience in previous roles within e.g Quality Assurance (QA), quality support
• NYS LPN or RN license
• Relevant previous work experience such as medical records review
• Time management, critical/creative thinking, project management, communication, and problem-solving skills
• Six-Sigma Green Belt Cortication
• Oversee QC activities that support cGMP production operations
• Work with other functional areas to provide Quality oversight of change controls, deviations, CAPAs, Work Orders, and ensure that related records are reviewed and approved, as appropriate
• Assist in the development of Standard Operating Procedures in order to maintain local quality systems in line with current regulations, client directives, and industry standards, as appropriate