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Hovione

CDMO for complex drug APIs manufacturing

QC Microbiology Analyst

Regulatory & Quality (Life Sciences)Posted on Nov 12
Full-timeLoures, PortugalNo salary listedIn-person

About the Job

Requirements

  • A Bachelor's degree in Microbiology, Biology, Biotechnology, Biochemistry, Pharmaceutical Sciences, or a related Life Sciences discipline is required.
  • At least 3 years of experience as an Analyst in a Pharmaceutical Microbiology Laboratory is required.
  • Strong knowledge of Good Manufacturing Practice (GMP) requirements and microbiological laboratory practices is required.
  • Experience performing microbiological testing in a pharmaceutical manufacturing environment is required.
  • Experience with microbiological investigations, deviations, and quality events is required.
  • Proficiency in laboratory documentation and data recording practices is required.
  • Good written and verbal communication skills in English are required.
  • Attention to detail and data accuracy are required.
  • Teamwork and collaboration skills are required.
  • The ability to communicate effectively across departments and functions is required.
  • Organisational and prioritisation skills are required.
  • Problem-solving ability and the ability to work independently are required.
  • Commitment to quality, compliance, and continuous improvement is required.
  • The ability to adapt and work in a dynamic operational environment is required.

Responsibilities

  • Perform microbiological testing according to approved methodologies, specifications, GMP requirements, and laboratory schedules.
  • Execute environmental monitoring, bioburden, endotoxin, water, microbial identification, and other microbiological analyses as required.
  • Complete testing accurately and within established timelines to support operational needs and laboratory key performance indicators.
  • Generate, review, and maintain laboratory data in compliance with GMP, data integrity, and health, safety, and environment requirements.
  • Maintain laboratory records, logbooks, worksheets, and electronic systems in accordance with internal procedures.
  • Maintain laboratory housekeeping standards and a safe, compliant working environment.
  • Perform routine calibration, verification, and preventative maintenance of laboratory equipment.
  • Identify and report equipment issues and support troubleshooting activities.
  • Manage laboratory consumables and help maintain adequate stock levels.
  • Identify, document, and communicate discrepancies, deviations, non-conformances, and laboratory incidents.
  • Support investigations related to out-of-specification results, out-of-trend results, atypical results, deviations, and quality events.
  • Participate in root cause analysis and implement corrective and preventive actions.
  • Support internal, customer, and regulatory audits as required.
  • Work with Production, Quality Assurance, and other site functions to support microbiological activities across the facility.
  • Conduct production-area sampling and environmental monitoring activities when required.
  • Communicate with stakeholders across departments to ensure timely resolution of laboratory-related issues.
  • Contribute to laboratory process improvements and operational excellence initiatives.
  • Seek additional information and technical knowledge to enhance performance and capability.
  • Participate in performance management, training, and development programmes.

Desired Qualifications

  • Previous experience in a contract development and manufacturing organization, pharmaceutical manufacturing, or biotechnology environment is preferred.
  • Knowledge of environmental monitoring programmes and contamination control strategies is preferred.
  • Experience supporting customer and regulatory inspections is preferred.
  • Familiarity with laboratory information management systems and electronic laboratory systems is preferred.

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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