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Cambrex

Global CDMO for drug substances

Quality Assurance Specialist

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timePaullo, Italy€40k - €50k /yrIn-person

About the Job

Requirements

  • A specialist degree in Chemistry, Industrial Chemistry, Pharmaceutical Chemistry and Technology, or Pharmacy.
  • Knowledge of Good Manufacturing Practices and their application in an active pharmaceutical ingredient manufacturing company.
  • Specialist skills in statistical data evaluation and GMP document management.
  • Knowledge of International Council for Harmonisation guidelines and the general chapters of the European Pharmacopoeia and United States Pharmacopeia.
  • Knowledge of written and spoken English.
  • At least 5–7 years of experience in a Quality Assurance function related to active pharmaceutical ingredients at a leading chemical-pharmaceutical or pharmaceutical company.
  • Experience managing documentation in a highly regulated environment, including data integrity and current Good Manufacturing Practices compliance.
  • Experience using statistical techniques and analyzing data.
  • Knowledge and experience using Microsoft Office, TrackWise or other Quality Management System software, SAP, and Laboratory Information Management Systems.

Responsibilities

  • Collaborate with the Quality Assurance Compliance Manager to critically review documentation supporting analytical method validations throughout the lifecycle of generic active pharmaceutical ingredients, including protocols, reports, and associated raw data, in accordance with company standard operating procedures and current regulatory requirements.
  • Evaluate and manage change-control activities related to revisions to analytical methods and specifications for finished active pharmaceutical ingredients, maintaining alignment with existing European Pharmacopoeia, United States Pharmacopeia, and Japanese Pharmacopoeia monographs.
  • Evaluate and manage change-control activities relating to specifications for raw materials, intermediates, in-process controls, and production Master Batch Records in the company enterprise resource planning system.
  • Participate in preparing documentation required for customer audits and regulatory inspections, and actively participate in audits of generic active pharmaceutical ingredients conducted by customers.
  • Participate in the internal audit program, including Good Manufacturing Practices, housekeeping, data integrity, and good documentation practices, in production departments and analytical laboratories.
  • Participate in Gemba walks in production departments and Good Manufacturing Practices laboratories to oversee housekeeping and good documentation practices.
  • Review process validation protocols and prepare related reports for generic active pharmaceutical ingredient processes and their lifecycle; support the Contract Manufacturing Organization team in reviewing and preparing the same types of documentation for active pharmaceutical ingredients transferred by customers.
  • Manage deviations and related investigations connected to generic active pharmaceutical ingredient processes, using company procedures and investigation methods such as root cause analysis, Five Whys, and Gemba.
  • Participate in supplier and service-provider qualification and manage related change controls.
  • Participate in scheduled risk assessments and prepare the related reports.
  • Provide support for the activities above relating to Contract Manufacturing Organization products when needed.

Desired Qualifications

  • Previous experience of 7–10 years in a chemical-pharmaceutical company.

About the Company

Cambrex

Global CDMO for drug substances

Cambrex is a global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, plus analytical and IND enabling services. It uses a range of specialized technologies—such as continuous flow chemistry, handling of controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and production of highly potent APIs—to develop and manufacture drug substances for clients. The company differentiates itself with over 40 years of experience, a staff of about 2,000 experts, and a global footprint in North America and Europe, offering end-to-end capabilities from early development through commercial-scale manufacturing. Its goal is to help clients bring new medicines to market by delivering integrated, reliable drug substance development and manufacturing and related analytical support.

Company size
1,001-5,000
Company stage
IPO
Headquarters
East Rutherford, NJ
Founded
1981

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