Microbiology QC Analyst - Biosimilar
Anonymized
Role Overview
Job Scope
The Microbiology QC Analyst is responsible for performing microbiological
analyses of raw materials, in-process products, and finished products to ensure
compliance with GMP requirements, product safety, and the quality of biosimilar
products. The role supports laboratory operations by ensuring accurate testing,
proper documentation, environmental monitoring, and adherence to biosafety and
data integrity standards.
Job Requirements
Education:
Bachelor’s degree to Master’s degree (Bac +3 to Bac +5) in:
Microbiology, Biotechnology, Pharmaceutical Sciences, Laboratory Sciences
Experience:
1to 3 years of experience in pharmaceutical microbiology
Knowledge of GMP / GxP environments
Experience in biotechnology or biosimilar production is considered a plus
Professional Knowledge
Knowledge of pharmaceutical microbiology techniques (culture, identification,
sterility testing, endotoxin testing)
Good understanding of Good Laboratory Practices (GLP) and GMP requirements
Experience in handling microbiological equipment (autoclaves, incubators,
laminar flow hoods, microscopes)
Knowledge of laboratory documentation and data traceability practices
MainCompetencies
High level of rigor and attention to detail
Strict adherence to procedures and quality standards
Ability to work effectively within a team and under supervision
Good organizational and analytical skills
Strong sense of responsibility and compliance mindset
Dutiesand Responsibilities
Perform microbiological control tests according to SOPs and validated methods.
Review and verify analytical results against established specifications.
Ensure strict application of GMP and biosafety requirements.
Document all analyses, observations, and test results in laboratory records
and reports.
Ensure data integrity and traceability in compliance with ALCOA+ principles.
Prepare, clean, and maintain microbiological laboratory equipment and
instruments.
Perform environmental monitoring activities (air, surfaces, purified water
testing).
Participate in the qualification and maintenance of microbiological
instruments.
Identify and report Out of Specification (OOS) and Out of Trend (OOT)
results.
Support investigations and CAPA implementation under the supervision of the
QC Supervisor.
Collaborate with QA and Production teams to resolve non-conformities.
Participate in microbiological method transfer and validation activities.
Contribute to laboratory process optimization and continuous improvement
initiatives.
Support internal audits and regulatory inspections.
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Niveau hiérarchique
Cadre supérieur
Type d’emploi
Temps plein
Fonction
Contrôle qualité
Secteurs
Fabrication de produits pharmaceutiques
Les recommandations augmentent vos chances d’obtenir un entretien chez MS PHARMA
Voir qui vous connaissez
**Détails de l'offre :**
- **Lieu de travail :** Algiers, Alger, Algérie
- **Secteur d'activité :** Fabrication de produits pharmaceutiques
- **Niveau de poste :** Cadre supérieur
- **Type de contrat :** Temps plein
- **Fonction :** Contrôle qualité
The Microbiology QC Analyst is responsible for performing microbiological
analyses of raw materials, in-process products, and finished products to ensure
compliance with GMP requirements, product safety, and the quality of biosimilar
products. The role supports laboratory operations by ensuring accurate testing,
proper documentation, environmental monitoring, and adherence to biosafety and
data integrity standards.
Job Requirements
Education:
Bachelor’s degree to Master’s degree (Bac +3 to Bac +5) in:
Microbiology, Biotechnology, Pharmaceutical Sciences, Laboratory Sciences
Experience:
1to 3 years of experience in pharmaceutical microbiology
Knowledge of GMP / GxP environments
Experience in biotechnology or biosimilar production is considered a plus
Professional Knowledge
Knowledge of pharmaceutical microbiology techniques (culture, identification,
sterility testing, endotoxin testing)
Good understanding of Good Laboratory Practices (GLP) and GMP requirements
Experience in handling microbiological equipment (autoclaves, incubators,
laminar flow hoods, microscopes)
Knowledge of laboratory documentation and data traceability practices
MainCompetencies
High level of rigor and attention to detail
Strict adherence to procedures and quality standards
Ability to work effectively within a team and under supervision
Good organizational and analytical skills
Strong sense of responsibility and compliance mindset
Dutiesand Responsibilities
Perform microbiological control tests according to SOPs and validated methods.
Review and verify analytical results against established specifications.
Ensure strict application of GMP and biosafety requirements.
Document all analyses, observations, and test results in laboratory records
and reports.
Ensure data integrity and traceability in compliance with ALCOA+ principles.
Prepare, clean, and maintain microbiological laboratory equipment and
instruments.
Perform environmental monitoring activities (air, surfaces, purified water
testing).
Participate in the qualification and maintenance of microbiological
instruments.
Identify and report Out of Specification (OOS) and Out of Trend (OOT)
results.
Support investigations and CAPA implementation under the supervision of the
QC Supervisor.
Collaborate with QA and Production teams to resolve non-conformities.
Participate in microbiological method transfer and validation activities.
Contribute to laboratory process optimization and continuous improvement
initiatives.
Support internal audits and regulatory inspections.
Show more
Show less
Niveau hiérarchique
Cadre supérieur
Type d’emploi
Temps plein
Fonction
Contrôle qualité
Secteurs
Fabrication de produits pharmaceutiques
Les recommandations augmentent vos chances d’obtenir un entretien chez MS PHARMA
Voir qui vous connaissez
**Détails de l'offre :**
- **Lieu de travail :** Algiers, Alger, Algérie
- **Secteur d'activité :** Fabrication de produits pharmaceutiques
- **Niveau de poste :** Cadre supérieur
- **Type de contrat :** Temps plein
- **Fonction :** Contrôle qualité