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Catalent

Global contract drug formulation, manufacturing, packaging

Quality Control Analyst

Regulatory & Quality (Life Sciences)Posted on Nov 13
Full-timeAprilia, Italy

About the Job

Requirements

  • A master's degree in a scientific subject (Chemistry or Pharmaceutical Chemistry and Technology), or a diploma as a chemical and/or industrial technician for chemical quality control.
  • At least one year of previous laboratory experience, preferably in the pharmaceutical sector.
  • Knowledge of relevant standards, legislation, and Good Manufacturing Practices.
  • Good knowledge of English.
  • Ability to work collaboratively, take initiative, work autonomously, and adapt flexibly.
  • Problem-solving orientation and determination in pursuing objectives.
  • Ability to operate in high-volume settings while managing multiple activities in parallel.

Responsibilities

  • Perform chemical analyses of raw materials, semi-finished products, packaging materials, stability products, and finished products according to approved methods, specifications, company procedures, and applicable national and international regulations.
  • Use and clean chemical laboratory instruments correctly, and complete calibration, qualification, and maintenance plans within planned timelines and costs.
  • Support the supervisor in drafting, reviewing, and correctly archiving chemical-laboratory documentation, including standard operating procedures, laboratory notebooks, logbooks, and registers; ensure documentation is readily available for internal, external, and regulatory inspections.
  • Report out-of-specification results to the supervisor for appropriate laboratory out-of-specification and out-of-trend management.
  • Complete work plans within planned timelines and costs.
  • Ensure adequate supply of laboratory consumables.
  • Report the operating and safety status of laboratory departments, rooms, and analytical instruments to the supervisor.
  • Manage laboratory reagents, standards, solvents, and solutions correctly, and ensure adequate supply of consumables.
  • Apply standard operating procedures correctly.
  • Ensure compliance with internal and corporate procedures and applicable regulations, cGMP, ISO 13485, ISO 22716, BRC, 21 CFR Part 111, and the HACCP Manual.
  • Organize and manage laboratory document and sample archives according to approved procedures and Good Laboratory Practices.
  • Perform ongoing stability testing according to the schedule and protocol, within the required timelines.
  • Support the supervisor in periodic evaluation of quality-management-system performance indicators to verify process consistency and reproducibility, identify adverse trends, and define necessary corrective and preventive actions.
  • Manage raw-material and finished-product samples in the chemical laboratory according to the relevant business line.

About the Company

Catalent

Global contract drug formulation, manufacturing, packaging

Catalent provides end-to-end contract development and manufacturing services for pharmaceutical, biotechnology, and consumer health products. Its offerings cover drug formulation, large-scale manufacturing, clinical supply, and packaging under long-term partnerships, coordinating through a connected supply chain to move products from development to market. It differentiates itself with a broad, integrated service platform and long-standing customer relationships that help clients accelerate development and ensure reliable supply. The company aims to help clients bring products to market efficiently while balancing quality, cost, and sustainability across the product lifecycle.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Franklin Township, NJ
Founded
1996

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