Qc Pds Reviewer Monza

Qc Pds Reviewer
Monza
Lombardia, Monza

Work Schedule

Flex Shifts 40 hrs/wk

**Environmental Conditions

Laboratory Setting, Office

At Thermo Fisher Scientific, we are on a mission to enable our customers to make the world healthier, cleaner, and safer.

With over $35 billion in revenues and the largest investment in research and development in the industry, we are a world-class organization that values performance, quality, and innovation.

Join our team and be a part of a successful, growing global organization where you will be encouraged to perform at your best and make significant contributions to the world.

As a QC PDS Reviewer, you will have a unique opportunity to be part of the PDS Analytical Development & GMP Department in our newly built Pharmaceutical Department.

Reporting to the PDS AD&GMP Analysis Reviewer Team Leader, you will be responsible for the reviewing phase of the raw data and documentation related to QC PDS Laboratory, ensuring the successful continuation of projects within the PDS.

**Responsibilities**:

- Perform tasks and activities directed by the PDS AD&GMP Reviewer Team Leader, in compliance with SOPs and safety regulations.

- Review and evaluate analytical data from various equipment (HPLC, GC, IR, UV-Spectrophotometer, and others) for small and large molecule analysis to support product development (API, Drug Product) and stability testing.

- Review analytical data for raw materials, in-process & finished products, formulations, and ensure compliance with SOPs and cGMP standards.

- Conduct reviews for Analytical Method Development, Transfer, and Validation, as well as routine and stability analysis.

- Maintain documentation following ALCOA principles and prepare raw data packages for clients.

- Participate in preparing scientific documents (e. g. , methods, protocols, reports, and SOPs).

- Contribute to laboratory safety programs, maintain an orderly environment, and oversee documentation of experiments.

- Verify and evaluate analytical documentation for data integrity, ensuring compliance with priorities and quality standards.

**Education and Experience

- Bachelor's degree in chemical pharmaceuticals, biology, chemistry, biotechnology, or a related field (Master's degree preferred) or equivalent experience.

- 2-3 years of laboratory experience, preferably in pharmaceuticals, biotechnology, healthcare, research, or academia.

- Proficiency in Office programs and laboratory computer systems.

- Knowledge of GMP standards and company procedures.

- Expertise in analytical techniques and instrumentation (HPLC, FT-IR, UV-VIS, etc.

).

- Experience in Analytical Method Development/Transfer and Validation.

- Familiarity with stability and routine tests for APIs and finished products.

**Languages

- Proficient in English.

**Skills and Traits

- Flexibility and adaptability.

- Strong organizational and planning skills.

- Effective listening and communication abilities.

- Teamwork and collaboration skills.