Quality Assurance Scientist

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Job description

Quality Assurance Scientist

Supports manufacturing operations areas OSD and Parenteral product such as Compounding, Filling, preparation, capping, Inspection, compression and packaging to assure that appropriate cGMPs are in place through frequent operations audit. Manages audit observations, investigations and CAPAs records in Trackwise on timely manner and participates in the investigations management process to identify root cause, evaluate and approves Corrective and Preventive actions CAPA s .and provides appropriate recommendations for the lot disposition. Reviews and approves the investigations occurred in the manufacturing process OSD and Parenteral products , facility and utilities, microbiology and warehouse areas. Reviews and approves the master documentation related to manufacturing and support areas such as CR s, SOP s, WPP s, BOM s, qualification and validation Protocols with government regulations and company Policies. Provides technical guidance and compliance support in the transfer of new products and process to maintain quality standards. Manages audit observations, investigations and CAPAs records in Trackwise on timely manner. Maintains management informed via frequent written reports of any problem that might affect the quality and/or timely release of materials. Performs product Acceptance Quality Level AQL during inspection parenteral products stage and distribute reserve and/or stability samples to the appropriate area.

Requirements:

Bachelor Degree in Science, Chemical Engineering, Biology, Pharmacy or Microbiology.
• 3 years of experience in the pharmaceutical industry.
• Minimum 1 year of experience in Quality Assurance responsibilities in a pharmaceutical industry.
• Knowledge of manufacturing operations of Solid Dosage and Parenteral Products Manufacturing.
• Strong knowledge of relevant GMP, FDA, EU regulations and the ability to interpret and apply them for intended use.
• Fully bilingual (Spanish/English) communication skills, both written and verbal are required.
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