QC Analyst - Biosimilar

مجهول

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JobScope
The QC Analyst is responsible for performing physicochemical, microbiological,
and biological analyses of raw materials, in-process products, finished
products, and packaging materials to ensure the quality and compliance of
biosimilar products with GMP and regulatory requirements. The role supports
laboratory operations through accurate testing, proper documentation, equipment
management, and adherence to data integrity standards.
Job Requirements
Education:
Bachelor’s degree to master’s degree (Bac +3 to Bac +5) in:
Pharmacy, Biotechnology, Analytical Chemistry, Pharmaceutical Sciences,
Laboratory Sciences
Experience:
1to 3 years of experience in a
pharmaceutical laboratory
Knowledge of GMP / GxP environments
Experience in biotechnology or biosimilar products is considered an advantage
Languages
Fluent in French
Basic technical knowledge of English (protocols, SOPs, reports)
Professional Knowledge
Knowledge of pharmaceutical analytical techniques (HPLC, UV, GC, ELISA,
microbiological testing)
Ability to read, interpret, and analyze analytical results
Good understanding of GMP standards and laboratory documentation practices
Basic knowledge of analytical method validation principles
MainCompetencies
High level of rigor and attention to detail
Strong respect for procedures and laboratory discipline
Good analytical and organizational skills
Ability to work effectively within a team and under supervision
Commitment to quality and compliance standards
Dutiesand Responsibilities
Perform analytical tests according to SOPs and validated methods (HPLC, GC,
UV, ELISA, microbiological testing, etc.).
Verify and review analytical results against established specifications.
Conduct routine analyses and support quality investigations when required.
Ensure strict compliance with GMP requirements during laboratory activities.
Accurately complete laboratory records, analytical reports, and
documentation.
Ensure data integrity in compliance with ALCOA+ principles and Good Laboratory
Practices.
Prepare, calibrate, and maintain laboratory instruments and equipment.
Report any equipment malfunction or maintenance requirement.
Participate in instrument qualification activities (IQ/OQ/PQ).
Identify and report Out of Specification (OOS) and Out of Trend (OOT)
results.
Support investigations under the supervision of the QC Supervisor.
Contribute to Corrective and Preventive Actions (CAPA).
Participate in analytical method transfer activities.
Contribute to the optimization of QC methods and laboratory procedures.
Support internal audits and external inspections under supervision.
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Niveau hiérarchique
Cadre supérieur
Type d’emploi
Temps plein
Fonction
Contrôle qualité
Secteurs
Fabrication de produits pharmaceutiques
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**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