Quality Assurance Consultant

hace 2 semanas

Buenos Aires, Argentina PQE Group A tiempo completo

We are a service provider company, l
eader in the Pharmaceutical and Medical Device sectors since 1998, with more than
1500 employees, 45+ nationalities and
30 subsidiaries all over the world (Europe, Asia and the Americas).

Joining PQE means being a part of a multicultural and challenging company, with
many local and international projects, and colleagues from all over the world.


Due to a constant growth PQE is looking for a
Quality & Compliance Senior Consultant based in
Buenos Aires, Argentina.


In this full-time role, the Quality & Compliance Consultant will participate in Quality & Compliance projects, such as support to clients for Health Authorities inspection readiness or post inspection remediation programs in the Pharmaceutical and Medical Devices Industries.

The Consultant will work alone or more frequently as part of multidisciplinary teams (either as leader or team member), depending on the nature and complexity of the project:

  • The Consultant will participate in Quality & Compliance projects, such as support to clients for Health Authorities inspection readiness or post inspection remediation programs.
  • Management of Health Authority inspections, from preparation to postinspection phase (e.g.
FDA, EMA, HEALTH CANADA).

  • General knowledge of Pharmaceutical processes and knowledge of Sterile Finished Dosage Forms manufacturing practices.
  • Expert in Quality Assurance tasks (e.g. PQR, Auditing, Change Control, Complaints, Deviations, CAPAs, OOS, Batch Record review, Documentation management, Training, Supplier Management).
  • Knowledgeable in Validation (i.e. Cleaning, Process).
  • Familiar in executing Risk Assessment (e.g. Process, Cross-Contamination).
  • Inspection readiness or postinspection remediation programs
  • Quality Management System improvement initiatives
  • Quality Assurance tasks.

Requirements:

  • Appropriate written and verbal communication skills in
    English and in any other relevant language(s)
-
Experience in
Quality Assurance in
Pharmaceutical processes and deep knowledge of Drug Product manufacturing practices (sterile injectable preferred)
(Not required):

  • Expertise in other
    QA tasks that include PQR, Auditing, Change Control, Complaints, Deviations, CAPAs, Batch Record reviews, SOPs, training, Qualification and Validation, etc.), Cleaning Validation, Process Validation and Risk Assessment
  • Knowledge and experience with aseptic processing
  • Previous
    experience with remediation plans for the
    FDA:
  • Availability to travel domestically and internationally

Location:
Buenos Aires, Argentina

Our collaborators are engaged, developed, challenged and
well-rewarded for performance.


We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing
practical processes and programs to identify, develop and inspire all our current and future leaders.



Tipo de puesto:
Tiempo completo

Salario:
$1,00 - $10,00 al mes

Idioma:

  • Inglés (Obligatorio)

Disponibilidad para viajar:

  • 75 % (Obligatorio)

  • Quality Assurance Specialist

    hace 2 semanas

    Buenos Aires, Argentina Stryker Corporation A tiempo completo

    What We Want- Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize, and automate.- Data communicators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive-level presentations.- ...

  • Quality Assurance Specialist

    hace 3 semanas

    Buenos Aires, Argentina Stryker Corporation A tiempo completo

    **What We Want** - ** Detail-oriented process improvers.** Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize, and automate. - ** Data communicators.** Highly effective communicators who can transform data findings into recommendations to compose reports and executive-level...

  • Quality Assurance Tester

    hace 3 semanas

    Buenos Aires, Argentina Soft Dev Team A tiempo completo

    We are seeking a talented QA Tester to join our team! If you are passionate about software quality, have experience in both automated and manual testing, and possess excellent English language skills, then this position is perfect for you! **Requirements**: - Minimum of 3 years of proven experience in quality assurance, both in automated and manual...

  • Quality Assurance Specialist

    hace 2 meses

    Buenos Aires, Argentina Stryker A tiempo completo

    What We WantDetail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize, and automate.Data communicators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive-level...

  • Quality Assurance Tester

    hace 2 semanas

    Buenos Aires, Argentina Soft Dev Team A tiempo completo

    We are seeking a talented QA Tester to join our team If you are passionate about software quality, have experience in both automated and manual testing, and possess excellent English language skills, then this position is perfect for youRequirements: Minimum of 3 years of proven experience in quality assurance, both in automated and manual testing. Deep...

  • Quality Assurance

    hace 2 semanas

    Buenos Aires, Argentina Typescouts A tiempo completo

    **Position**: Quality Assurance Specialist **Working Hours**: Monday - Friday, 9 am - 5 pm EST - working in North American company **Salary**: $1400 - $2000 USD / month Please submit your resume in English. **About the Company**: **We offer two main products**: a member data platform, and a web and e-commerce platform. Our member platform is the world's...

  • Control manager – Quality Assurance Associate

    hace 2 meses

    Buenos Aires, Argentina JPMorgan Chase & Co. A tiempo completo

    You will bepart of the LATAM and Canada (LAC) Central Control Office. LAC Legal Entity Risk Assessment Quality Assurance Control Manager is responsible for the design and execution of 1st Line of defense ( 1LOD) legal entity risk assessments across multiple jurisdictions, all businesses, and corporate functions in LAC .  As an associate you will have key...

  • Quality Assurance Engineer

    hace 4 semanas

    Buenos Aires, Argentina Shaw and Partners A tiempo completo

    **Who we are and what we do** Shaw and Partnersis a software development provider for high-profile startups with approximately 25 remote staff. We are also incubating two startups.Christopher Shaw, the founder and CEO, would be your manager. **Working at Shaw and Partners** Our clients have funded U.S. startups in LA and NY, so depending on your location,...

  • Senior Auditor, Quality Assurance

    hace 3 semanas

    Buenos Aires, Argentina ICON A tiempo completo

    **JOB: Senior Auditor, Quality Assurance** **Preferred Locations: EMEA** / Mexico / Argentina** ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health...

  • Control Manager

    hace 3 días

    Buenos Aires, Argentina JPMorgan Chase & Co A tiempo completo

    **JOB DESCRIPTION** You will bepart of the LATAM and Canada (LAC) Central Control Office. LAC Legal Entity Risk Assessment Quality Assurance Control Manager is responsible for the design and execution of 1st Line of defense ( 1LOD) legal entity risk assessments across multiple jurisdictions, all businesses, and corporate functions in LAC. In partnership...

  • Project Manager

    hace 7 días

    Buenos Aires, Argentina DTC PAges LLC A tiempo completo

    **Job Description**: - **Job Title**:Project Manager & Quality Assurance Tester - **Location**:Remote - **Type**:Full-time - **Salary**:2000 USD - **Seniority**: Mid-level or Senior **About Us**: DTC Pages is a conversion rate optimization agency specializing in helping Shopify stores scale and succeed. Our clients are ambitious Shopify store founders and...

  • Software Quality Assurance Analyst

    hace 2 semanas

    Buenos Aires, Argentina AYIGROUP A tiempo completo

    **Your role in our team**: The software quality assurance analyst will collaborate with software developers, solution delivery analysts, scrum masters, release managers to help deliver high quality solutions. This role will report to the release manager and will be a key contributor in delivering complex cross-functional projects in our customer’s...

  • Quality Assurance Engineer

    hace 2 semanas

    Buenos Aires, Argentina Fulcrum Digital A tiempo completo

    Type of Job: Remote position in LATAMAbout the Company: Fulcrum Digital is a prominent IT services and business platform firm. We collaborate with global organizations spanning various sectors such as banking, insurance, education, food services, retail, manufacturing, and eCommerce. Specializing in digital transformation, machine learning, and cutting-edge...

  • Quality Assurance Engineer

    hace 2 semanas

    Buenos Aires, Buenos Aires C.F., Argentina Ana Tabanera IT Recruiting A tiempo completo

    Están en búsqueda de Quality Assurance Engineer (Manual)Roles y responsabilidades:Diseño y ejecución de Casos de test. Reporte y seguimiento de defectos.Generación de datos de prueba Modalidad de trabajo: Híbrida (Se espera que quien se sume pueda ir a la oficina 2 veces x mes para encuentros y eventos.)Lugar de trabajo: Palermo, CABAContratación:Full...

  • Quality Assurance Lead

    hace 2 semanas

    Capital Federal, Buenos Aires, Argentina ByB Consultores A tiempo completo

    ¡Atención provincias de Buenos Aires y Santa Fe! Seleccionamos Quality Assurance Lead para Agrality, destacada empresa argentina de soluciones agroindustriales con unidades de negocios en Argentina, Estados Unidos y Brasil **‍ Modalidad de trabajo**: Presencial - Full time ¿Qué desafíos te esperan? ✔️Identificar, contratar y supervisar a los...

  • Software Quality Assurance Analyst

    hace 2 semanas

    Buenos Aires, Buenos Aires C.F., Argentina Business Commercial Management A tiempo completo

    BCM Uruguay is Hiring Software Quality Assurance Analyst Nível de inglés avanzado Residir en LATAM WE CREATE EMPOWERED LEADERS At Our customer we firmly believe that our People and our Culture are the secrets to our success so we give you unlimited access to everything you need to provide technical solutions on our IT Team. Our IT team is responsible for...

  • Quality Assurance Lead

    hace 2 semanas

    Buenos Aires, Buenos Aires C.F., Argentina ByB Consultores A tiempo completo

    Atención provincias de Buenos Aires y Santa FeSeleccionamos Quality Assurance Lead para Agrality, destacada empresa argentina de soluciones agroindustriales con unidades de negocios en Argentina, Estados Unidos y Brasil‍ Modalidad de trabajo: Presencial - Full time¿Qué desafíos te esperan?Identificar, contratar y supervisar a los proveedores y/o...

  • Quality Assurance Engineer

    hace 3 semanas

    Capital Federal, Buenos Aires, Argentina Ana Tabanera IT Recruiting A tiempo completo

    Están en búsqueda de Quality Assurance Engineer (Manual). Roles y responsabilidades: Diseño y ejecución de Casos de test. Reporte y seguimiento de defectos. Generación de datos de prueba Modalidad de trabajo: Híbrida (Se espera que quien se sume pueda ir a la oficina 2 veces x mes para encuentros y eventos.) Lugar de trabajo: Palermo, CABA....

  • Quality Assurance Engineer

    hace 2 semanas

    Buenos Aires, Argentina Fulcrum Digital A tiempo completo

    Type of Job: Remote in LATAM Contract **About us** Fulcrum Digital is a leading IT services and business platform company. We partner with global companies from diverse industries, including banking and financial services, insurance, higher education, food services, retail, manufacturing, and eCommerce. With expertise in digital transformation, machine...

  • Quality Assurance Automation

    hace 2 semanas

    Buenos Aires, Buenos Aires C.F., Argentina Readiness Global A tiempo completo

    Somos Readiness Global, Consultora Internacional especializada en Transformación Organizacional.Actualmente contamos con oficinas en 7 países y operamos en más de 10 y seguimos expandiéndonosEn esta oportunidad nos encontramos en búsqueda de un Quality Assurance Automation *, para unirse a nuestro equipo de consultoría, que prestará servicios de forma...