Quality Auditor
Avantorinc-ch
Rožnov pod Radhoštěm, CZE
před 2 dny

Job Summary

The Quality Auditor works closely with various departments to perform and validate test cases based on quality requirements, and recommend changes to predetermined quality guidelines.

Responsible for ensuring that the end product meets the minimum quality standards, is fully functional and user-friendly.

Interpret and implement quality assurance standards and provide accurate and comprehensive feedback to colleagues. Develop and execute test plans to ensure that all objectives are met.

Implement and monitor test scripts to assess functionality, reliability, performance, and quality of the service or product.

Identify and remedy defects within the production process.

The Corporate Quality Auditor will support the global supplier and corporate auditing process across all Avantor sites. He / she will coordinate and conduct audits to ensure compliance with company procedures and the quality standards to which the product(s) are purchased or manufactured.

The Corporate Quality Auditor will address all facets of relationship management including auditing for all suppliers of FDA regulated products (Excipient, API, Medical Device, Food grade), contract testing laboratories, and primary packaging suppliers using company procedures and regulations and / or industry guidance documents.

In addition to supplier auditing, the Corporate Quality Auditor will be instrumental in standing up a Corporate Auditing framework.

He / she will help the company maintain FDA compliance by lowering our risk on regulated items and confirming high quality of new suppliers.

MAJOR JOB DUTIES AND RESPONSIBILITIES (Listed in order of importance)

  • Leads and performs on-site quality system audits in accordance with Avantor procedures and FDA regulations (and / or international guidance’s) and prepares associated and required report documentation
  • Assists in writing and updating Policies, Procedures, WI and Forms for the Global Supplier Management Lifecycle, and the Corporate Quality Auditing framework.
  • Initiates, evaluates, and completes internal Management of Change, (MOC) resulting from supplier changes
  • Accountable for supplier risk evaluation within Avantor new product setup process
  • Point of Contact for customer audits of Avantor manufacturing sites, specifically to address Supplier Management and Corporate Auditing topics
  • Coordinates with customers for release of audit Executive Summaries
  • Works closely with the Compliance Team to identify best practices for deploying the Supplier Management Lifecycle to all locations globally
  • QUALIFICATIONS (Education / Training, Experience and Certifications)

  • Bachelor of Science degree in chemistry, biology, natural science, or related field is required. An emphasis on quality or chemical discipline is preferred Minimum of ten (10) years of experience in Quality Assurance in a GMP manufacturing / packaging / testing environment
  • ASQ Certified Quality Auditor (CQA) certification (or equivalent) preferred
  • Experience as a Quality Auditor either internal or supplier for ISO 9001 : 2015, 14001, 13485, IPEC, USP General Chapter
  • ICH Q7, ICH Q9

  • Comprehensive understanding of FDA regulations for food, pharma and medical devices, ICH Guidelines, IPEC, USP / NF, European Directives, and other cGMP requirements
  • Strong familiarity with and understanding of regulatory and quality assurance procedures, systems, and operations
  • Experience with SAP highly preferred
  • Skills / Competencies :

  • Detail oriented
  • Strong sense of urgency, initiative, drive
  • Demonstrated strong interpersonal skills
  • Ability to meet tight deadlines
  • Demonstrated ability to multi-task
  • Excellent listening and communication skills
  • Ability to interpret an extensive variety of information in written, verbal and diagram formats
  • High level of professionalism and good judgment
  • Strong organizational and prioritization skills
  • Ability to deal effectively with people in all situations and at all levels and differing cultures.
  • Strong project management skills and ability to work independently and effectively manages time
  • Ability to read, analyze, and interpret common and technical journals, financial reports, and legal documents. Familiarity with chemical nomenclature and manufacturing terminology, required
  • Ability to learn and navigate multiple software systems readily
  • ORGANIZATIONAL RELATIONSHIPS / SCOPE :

    The Corporate Quality Auditor will report directly to the Global Director, Supplier Quality and interact with the Global Compliance team on a regular basis.

    He / she will interact with both internal and external contacts at all levels of the organization including Global Procurement, Marketing, suppliers, Avantor Site Quality Heads, and external customers.

    WORKING CONDITIONS :

    The work environment is an office setting. The duties of the job will require the Corporate Quality Auditor to travel approximately 75% of the time, both domestically and internationally.

    DISCLAIMER :

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

    They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

    Avantor is proud to be an equal opportunity employer.

    EEO Statement

    We are an Equal Employment / Affirmative Action employer. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state / province, or local law.

    If you need a reasonable accommodation for any part of the employment process, please contact us by email at TalentManagement avantorsciences.

    com and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis.

    Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

    For more information about equal employment opportunity protections, please view the Equal Employment Opportunity is THE LAW Poster, EEO is the Law Poster Supplement, and Pay Transparency Non-Discrimination Provision using the links below.

    OFCCP EEO Supplement

    PAY TRANSPARENCY NONDISCRIMINATION PROVISION

    3rd party non-solicitation policy

    By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions.

    Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation

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