C&Q Calificación de equipos

Are you ready to join a
world leader
in the exciting and
dynamic fields of the Pharmaceutical and Medical Device industries
?
PQE Group
has been at the forefront of these industries since 1998, with
40 subsidiaries
and more than
2000 employees in Europe, Asia, and the Americas
.

Job Overview

We are looking for C&Q Freelancers in Buenos Aires Argentina.

Main Responsabilities:

• Development of qualification plans, user/technical requirements specifications, design qualification reports, test plans, requirements-testing traceability matrixes, qualification summary reports
• Development of installation, operational and performance qualification protocols for equipment and utilities (e.g.: HVAC, Water Systems, Process Gases), according to the current internationally recognized guidelines (e.g.: ISPE, GAMP)
• Expertise in CQV activities of HVAC, Clean utilities, Temperature mapping.
• Development of thermal validation study protocols
• Knowledge of the main test instruments suites (e.g.: Client Kaye Validator, Thermal validation studies data loggers, HVAC test instruments, calibration instruments).
• Coordination of junior resources for qualification testing execution and use of test instruments
• Development of calibration and maintenance plans and related instructions.
• Development of standard operating procedures
• Ensure all project-related issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval)
• Preparation of project and life‐cycle reports and review/approve all other documents to ensure compliance with SOP.
• Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in the document repository (Document Navigator) and approved following the prescribed SOP +10 years of experience in a similar role.
• Manage periodic validation review and re-validation testing.
• Promote engineering/qualification best practices, client Standard Operating Procedures (SOP), and Good Manufacturing Procedures (GMP) regulations.
• Work with client validation teams to ensure all C&Q activities are in compliance with local and federal regulations.
• Update and execute change controls to qualified facilities, equipment, and utilities.

Requirements

• At least 5 years of C&Q experience in FDA regulated manufacturing facilities.
• Bachelor's Degree in Science, Business, or related field.
• Experience in GMP sterile and biotech processes that includes upstream & downstream manufacturing.
• Strong understanding of FDA regulations for commissioning, validation, and lifecycle management of GMP equipment and systems.
• Knowledge of regulations and guidelines applicable to computerized and automated systems (GAMP, 21 CFR part 11,).
• Ability to manage priorities, deliverables, and schedule milestones.
• Requires strong interpersonal, verbal communication, and technical writing skills in English.

Next Steps

Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive feedback coming from the Hiring Manager interview, the recruiter will contact you for the next steps or to discuss our proposal. Alternatively, if the feedback is negative, we will contact you to halt the recruitment process.

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us.