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Résumé du poste
A leading pharmaceutical packaging company in Santiago de Querétaro seeks a quality assurance specialist to ensure GMP compliance and manage quality alerts. Candidates should possess a Bachelor's degree and have 1 - 3 years of experience with a focus on aseptic processes and quality management. Join a team dedicated to maintaining high standards in pharmaceutical packaging, and contribute to the reliability of our products.
Qualifications
- 1 - 3 years of experience required.
- Knowledge of applicable regulations for primary packaging material suppliers.
- Experience with instrument calibration is essential.
Responsabilités
- Ensure compliance with Good Manufacturing Practices (GMP).
- Provide and report quality alerts to the production leader.
- Segregate affected products for re-inspection.
Connaissances
Formation
Company Description: Gerresheimer Querétaro S.A. in Mexico produces primary glass packaging for pharmaceutical use. Type I glass is produced in clear and amber glass. The broad product range includes ampoules, serum vials, screw thread vials, ready-to-fill syringes and cartridges.
Ensure compliance with Good Manufacturing Practices (GMP) in order to promptly provide and report quality alerts to the production leader, enabling immediate corrective actions to minimize impact on the production schedule.
Properly segregate affected products to carry out the re-inspection process, following the established AQL levels for each type of defect, thereby ensuring the reliability and quality assurance of Ready-to-Fill (RTF) products.
- Bachelor's degree
- 1 - 3 years of experience
- Experience in aseptic processes
- Quality manegement
- Quality control and assurance
- Experience in calibration
- Basic knowledge of terminal sterilization processes
- Equipment calification
- Instrument calibration
- Applicable regulations for primary packaging material suppliers in the pharmaceutical, cosmetics, and medical device industries
* Le salaire de référence se base sur les salaires cibles des leaders du marché dans leurs secteurs correspondants. Il vise à servir de guide pour aider les membres Premium à évaluer les postes vacants et contribuer aux négociations salariales. Le salaire de référence n’est pas fourni directement par l’entreprise et peut pourrait être beaucoup plus élevé ou plus bas.
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