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Pds Analytical Development

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The Quality Difference at

Thermo Fisher Scientific:

What makes our quality teams unique is a shared passion for getting it done right the first time and working for the right reasons with our customers always in mind.

Our team of Quality professionals understand our customers rely on the accuracy, safety, and effectiveness of our products and services that are improving lives around the world.

When you join our team of quality professionals, you'll collaborate on projects on a global scale while being encouraged to grow your skills and discover new career paths with us.


When you're part of Thermo Fisher Scientific, you'll do challenging work, and join a team that values performance, quality and innovation.

As part of a successful, growing global organization you will be encouraged to perform at your best.

With revenues of more than $35 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

Monza offers compliance with controlled drug regulations in Europe and the U.S.

as well as disposable manufacturing technologies and fully integrated secondary packaging services, and has received regulatory approval from various international regulatory inspection agencies, including:
ANVISA, JP PMDA, US FDA, EMA, GCC States, Canada, Russia, Taiwan, Turkey.

The Monza site currently supplies over 20 countries - all the major international markets, including the U.S., Europe and Asia Pacific.


Reporting to the PDS AD&GMP Supervisor they are responsible for the assigned projects, responsible for all the documentation related to QC PDS Laboratory in such a way as to ensure the successful continuation of the projects within the PDS.

Collaborates with all the functions within the company in the implementation of analytical requirments respecting the company quality standards.


Collaborate for the analytical documentation of APIs, Excipients and DP (release and stability tests), preparing the analytical method and supporting the upload of these on the computerized systems.


Collaborate with Clients, QC PDS, Regulatory Department, QC Compliance, QA and QO in order to issue the correct documents for PDS projects, respecting the ICH and Pharmacopoeia.


You will a part, supported by the QC Documentation Team, of discussion about compliance consulting and strategic advice to internal and external clients to determine the most appropriate approach in order to have compliant documentation for their products.


Will be a part, supported by the QC Documentation Team, to project specific strategy, technical expertise in QC Documentation matter and collaboration oversight for key client's projects.

With the QC Documentation team will be an executive contact for key clients for all issues, including attendance at regulatory authority meetings and other public relation functions.

Ensures quality performance for key/managed projects.


In this role will be part of a cohesive team responsible for Deviations, CAPAs, and Change Controls for all phases of PDS Projects.

You will improve of analytical skills cGMP regulations to ensure full Quality compliance.

Works supporting the QC PDS Documentation Team performing work that consistently support Client's expectation and respect of Client's timelines.


Collaborate with the Team to plans for future customer activities and solicit other projects that are aligned with the company goals & objectives.


Contribute to updating the procedures relating to the area of competence, by drafting and reviewing them as needed, in compliance with current regulations, laws and GMP standards.

Contributes the continuous updating of the procedures concerning the area of competence in the drafting and updating of the same, in compliance with current regulations (current EU GMP, US GMP)


Support the Qc Documentation team to perform laboratory investigations, laboratory OOS and OOT and any deviations and CAPA related to the PDS Projects.


Collaborate for the evaluation of OOS, OOT and laboratory investigation in terms of recurrences, root cause, trend and define CAPAs.


Relationships:

INTERIORS

  • Production departments
  • QA
  • Regulatory
  • Logistics
  • TT / Business

Exterior

  • Clients
  • External laboratories

Requirements and qualifications:
-
ESSENTIALS
Bachelor's degree in chemical engineering, chemistry, or equivalent degree

Technical and IT knowledge:

GMP standards applied to Quality Control laboratories, with particular reference to stability studies

Knowledge of laboratory concepts and computer programs
Knowledge of data management and evaluation systems

Professional experiences:

In the laboratory of analysis at university or pharma companies

Languages:

English

Personality traits:

  • Flexibility and adaptability.
  • Good organization and planning skills
  • Excellent listening, oral, and written communication skills
  • Ability to work in a team
At Thermo Fisher