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Hovione

CDMO for complex drug APIs manufacturing

Quality Control Analyst

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeLoures, PortugalNo salary listedIn-person

About the Job

Requirements

  • A high school diploma is mandatory.
  • A qualification in a relevant chemistry, analytical chemistry, chemical engineering, pharmaceutical-related, or other science-related field is mandatory.
  • Relevant work experience is required.
  • Proven practical pharmaceutical or related industry experience in a GMP-regulated quality-control laboratory environment is mandatory.
  • Technical understanding of GMP practices, analytical theory, and techniques is required.
  • Clear and open written and verbal communication skills are required.
  • Competence with computers and knowledge of the Microsoft Office package are required.
  • The candidate must be able and available to work in shift patterns as required by business needs.
  • The candidate must have the knowledge, experience, and skills to perform tasks in accordance with established rules and procedures.

Responsibilities

  • Define and implement quality-control techniques to verify the quality of raw materials, intermediate and end products, and other analytical services, in accordance with regulatory requirements.
  • Manage and control quality-control activities in accordance with quality-assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
  • Organize and define daily priorities for assigned tasks to perform allocated sample analysis accurately and promptly and meet the periodic laboratory plan and area key performance indicators.
  • Adhere to the laboratory testing schedule to support an efficient quality-control system.
  • Take responsibility for individually generated data and ensure it complies with applicable good manufacturing practice requirements and health, safety, and environmental regulations, operating procedures, and industry standards.
  • Maintain checklists, laboratory records, and notebooks to good manufacturing practice standards and in accordance with internal procedures.
  • Maintain hygiene and housekeeping within the laboratory.
  • Perform routine calibration and corrective and preventive maintenance of designated laboratory instruments, and request required instrument parts and consumables.
  • Bring testing or work-practice discrepancies, deviations, and non-conformances to quality-control management's attention in accordance with internal procedures.
  • Issue events and support investigations of out-of-specification, out-of-trend, or atypical results, deviations, and quality-control incidents generated in the quality-control laboratories.
  • Communicate with internal departments regarding quality-control work using appropriate company processes and information-technology platforms.
  • Assist with audits as required and follow quality-control management instructions.
  • Undertake additional tasks to support laboratory activities as required.
  • Seek additional information when available information is insufficient.
  • Complete annual performance-review requirements, including self-assessment.
  • Perform assigned tasks safely and comply with environmental, health, and safety rules, procedures, regulations, and codes of practice.
  • Ensure facility activities comply with good manufacturing practice, legal, health, safety, and environmental regulations, and applicable standards in the country of operation; comply with and enforce company processes and good practices.

Desired Qualifications

  • Experience with good manufacturing practice and health, safety, and environmental standards is preferred.
  • Competent written and verbal English is preferred for sites where English is not the first language.

About the Company

Hovione

CDMO for complex drug APIs manufacturing

Hovione is a contract development and manufacturing organization that creates and scales active pharmaceutical ingredients (APIs) for medicines. It handles complex chemistry and specializes in processes like particle engineering and spray drying to improve drug absorption. It differentiates itself through a long history of tackling difficult compounds, deep manufacturing expertise, and an FDA-inspected global footprint across Portugal, Ireland, China, and the US. Its goal is to help drug developers bring new medicines to market efficiently by providing high-quality, scalable manufacturing and expanding capacity, especially in the U.S.

Company size
1,001-5,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Loures, Portugal
Founded
1959

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