Avantorinc-ch

Supervisor de Calidad (BB-C2039)

Encontrado en: Neuvoo CR

Descripción:
The QA Supervisor supports the organization in complying with, as well as the ongoing preparation and monitoring of conformance to, the requirements of government regulations and/or regulatory agencies and customers.
Performs inspection/audit readiness and manages activities during regulatory inspections and customer audits across. Prepares document packages for regulatory inspections/customer audits from all areas of company and for internal audits. May serve as point of contact for interactions with regulatory agencies for defined matters.
Performs evaluation of internal operations, controls, communications, risk assessments, and maintenance of documentation as related to QA compliance and recommends appropriate changes. Conducts and facilitates internal audits to identify, evaluate, disclose, and appropriately remedy risks and deficiencies. Assures compliance with all applicable standards and regulations (e.g., ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, and EXCiPACT).

PRINCIPALES TAREAS Y RESPONSABILIDADES (Lista en orden de importancia)

  • Oversee the QA compliance for Quality Management Systems.
  • Performs inspection/audit readiness and management activities during regulatory inspections and customer audits to ensure a consistent approach during inspections, adequate preparation of subject matter experts (SMEs). This includes, but is not limited to; leading ready room operation, obtaining and reviewing requested documentation, and preparing SMEs prior to interactions with auditors and accompanies inspectors during facility tours.
  • Acts as QA Compliance SME on cross-functional teams and in development and facilitation of cGMP and other QA training programs.
  • Supports the SACM management associated with the outputs of all audits and other NC ́s.
  • Responsible of the ISO QMS & preparation of the organization for ISO (re)certification
  • Coordinate company quality metrics (KPI) and conduct leadership reviews in conjunction with Quality Management representatives and company leaders.
  • Monitor compliance with Avantor training standards and documents
  • Support company training and SOP portal ATC
  • Collaborate with global QA and other QA-representatives within Avantor to further develop local and global QMS-system
  • Serves as resource for inquiries, facilitates cross-functional review of guidance or procedures.
  • Identifies compliance gaps, and develops, writes, revises, and reviews procedures, when needed. Recommends areas for workflow efficiency and improved resource management.
  • Collaborates with other departments and conforms to the established company policies, procedures, objectives, and goals.
  • Identifies trends and provides recommendations for corrective actions (e.g., CAPAs) to eliminate documentation/departmental errors.
  • reviews trending of quality metrics on a weekly, monthly, and quarterly basis
  • Assists with customer complaints via the Complaint Investigation team to formulate proper results and necessary testing that is needed in order to complete proper documentation and closure of complaint.
  • Support with documentation and rules of safety and government.
  • Perform special projects according to business needs.
  • Performs other tasks as assigned.
  • QUALIFICATIONS (Education/Training, Experience and Certifications)

  • Bachelor’s degree in Life or Industrial Sciences or related scientific discipline science, chemistry or engineering
  • 3 + years of experience in pharmaceutical, GMP, GDP, or ISO industry and working in QA environment
  • Bilingual (Spanish and English), a must
  • Experience in defining and implementation of processes and regulations
  • KNOWLEDGE SKILLS AND ABILITIES (Those necessary to perform the job competently)

  • Knowledge of GMP, GDP and ISO standards
  • Intermediate level Excel, MS Word, Power Point, Internet or related
  • Knowledge and experience utilizing a laboratory information management system (LIMS) and an Enterprise Resource Planning (ERP) system is preferred
  • Strong communication, organization and presentation skills required
  • Trainer experience
  • Effective supervisory, coaching and evaluation skills
  • Required proven knowledge on ISO 9001:2015 standards. Knowledge in any other regulation as: ISO 13485, 21 CFR 820, 21 CFR 11, ISO 17025, or EXCiPACT is considered a plus.
  • Previous experience hosting customer audits is preferred.
  • ENVIRONMENTAL WORKING CONDITIONS & PHYSICAL EFFORT (Under Typical Positions)

    The work environment characteristics and physical effort described here are representative of those an associate encounter while performing the essential functions of this job.

    While performing the duties of this job, the associate is exposed to an industrial warehouse environment. The associate works near moving mechanical machinery and moderate noise level.

    The job requires working in heights, exposure to changes in temperature, driving equipment, and maybe exposed to dust, fumes, or gases. Physical effort is required. Work require walking, standing, bending, reaching, lifting or carrying objects that typically weigh more than 25 lbs.

    Specific vision abilities required by this job include close vision, peripheral vision, depth perception, and the ability to adjust focus.

    Associate may be exposed to areas with Penicillin, Aspirin, Alcohol, Acetone and other fumes. Personal protective equipment required (safety shoes, respirators, gloves, safety glasses and laboratory coats required.

    Traveling required.

    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.

    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 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.

    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

    calendar_todayhace 8 horas

    report

    info Full time

    location_on Heredia, Costa Rica

    work Avantorinc-ch

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    Autorizo expresamente a la Términos y condiciones

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