QC Validation analyst

Amaris Consulting

Latina

In loco

EUR 26.000 - 50.000

Tempo pieno

4 ore fa
Candidati tra i primi

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Vantaggi offerti da questo lavoro

International community
Internal Academy training
CSR Programs
Robust benefits

Descrizione del lavoro

Amaris Consulting is seeking a QC Validation Analyst to join our team in an international, fast-growing organization. You will perform chemical analysis using HPLC with Empower3 and develop/validate analytical methods per ICH and GMP guidelines.

Ideal candidates have 2–3 years of HPLC experience, strong cGMP knowledge, and a degree in Chemistry or related field. Fluent Italian and good English are required; you will work in a regulated environment and contribute to cross-functional product

Competenze

  • 2–3 years of experience with HPLC analysis using Empower3.
  • Knowledge of cGMP and QC laboratory procedures in the pharmaceutical industry.
  • Degree in Chemistry, Pharmaceutical Chemistry and Technology or related field.
  • Experience in analytical method validation in a GMP-regulated chemistry laboratory.
  • Fluent Italian and good command of English.
  • Ability to work precisely and efficiently in a regulated environment.

Mansioni

  • Perform chemical analysis using HPLC with Empower3 software
  • Execute and document QC testing activities in compliance with GMP guidelines
  • Design and execute validation protocols for analytical methods (e.g., HPLC, GC, UV-Vis) in compliance with ICH and GMP guidelines
  • Perform validation experiments to assess accuracy, precision, specificity, linearity, range, detection and quantitation limits, robustness, and system suitability
  • Prepare and review validation documentation, including protocols, reports, and risk assessments
  • Support method transfer and verification activities between laboratories or from R&D to QC
  • Collaborate with cross-functional teams to ensure product quality compliance

Conoscenze

HPLC
Empower3
Quality control
GMP knowledge
Italian
English

Formazione

Degree in Chemistry or related field

Strumenti

Empower3 software

Descrizione del lavoro

Join our team as QC Validation Analyst and start a new adventure in an international and dynamic environment where you will be able to fulfil your career expectations in a fast‑growing organization.

Being a consultant at Amaris Consulting means positioning yourself as a technical and functional expert in an industrial field, but above all being an ambassador of our organization to clients thanks to your interpersonal skills and ability to listen in order to build a strong relationship of trust with our clients and fully understand their challenges and issues, as well as your curiosity and eagerness to learn as we support over 1000 clients from all sectors worldwide.

Responsibilities
  • Perform chemical analysis using HPLC with Empower3 software
  • Execute and document QC testing activities in compliance with GMP guidelines
  • Design and execute validation protocols for analytical methods (e.g., HPLC, GC, UV‑Vis) in compliance with ICH and GMP guidelines
  • Perform validation experiments to assess accuracy, precision, specificity, linearity, range, detection and quantitation limits, robustness, and system suitability
  • Prepare and review validation documentation, including protocols, reports, and risk assessments
  • Support method transfer and verification activities between laboratories or from R&D to QC
  • Collaborate with cross‑functional teams to ensure product quality compliance
Qualifications
  • 2‑3 years of experience with HPLC analysis using Empower3 software
  • Knowledge of cGMP and QC laboratory procedures in the pharmaceutical industry
  • Academic background: Degree in Chemistry, Pharmaceutical Chemistry and Technology or related field
  • Experience in analytical method validation in a GMP‑regulated chemistry laboratory
  • Fluent Italian and good command of English
  • Ability to work precisely and efficiently in a regulated environment
Benefits
  • An international community bringing together 110+ different nationalities
  • An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
  • A robust training system with our internal Academy and 250+ available modules
  • A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
  • Strong commitments to CSR, notably through participation in our WeCare Together program
  • Gross Annual Salary (GAS): EUR 26,000–EUR 50,000; basic salary only, the variable component will be detailed in the offer
Equal Opportunity Employer

Amaris Consulting is proud to be an equal‑opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability or other characteristics.

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