Quality Assurance Consultant

hace 3 días


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 post-inspection 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 post-inspection 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)



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