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Quality Assurance Specialist
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Support, Client
Projektbeschreibung
Quality Assurance Specialist
Our client, a leading pharmaceutical organisation is currently seeking a Quality Assurance Specialist.
Location: Basel area
Duration: 6 month which might be extended
Start: ASAP
Job Duties/Responsibilities
The Quality Assurance Specialist will assist in the preparation of release packages for approval by the Manager of Lot Disposition and within established standard lead times. This work contains
review of batch records, deviation reports, chromatograms, batch reports and other quality records to support the lot release of commercial bulk products.
Report any issues, deviations, investigations or trends discovered during the lot review to Genentech quality management for review and approval per Genentech policies and procedures.
Work on other projects to support quality managers as needed in administrative work, Quality Risk Assessment, Audit tracking and closure, support of regulatory filings, commissioning, annual
product quality reviews, change control, metrics and other possible areas.
Interact on an ongoing basis with site quality managers to solve any quality issues.
Support the transport, storage and archiving of paper and/or electronic quality documents from the PTQXA manufacturing sites.
Technical Duties/Responsibilities:
Management of batch record review activities to ensure that products are dispositioned in accordance with regulatory requirements, cGMP's and Genentech/Roche policies and procedures, within standard lead times.
Interfacings with appropriate departments or manufacturing plants to ensure that lot disposition items are completed.
Notification to Senior Management for all known delays in meeting established standard lead times or any potential quality issues.
Interfacing with QA Lot Disposition Supervisors to ensure that final review activities are completed.
Performing a review of investigations for potential cumulative effect to a batch history record.
Performing a review of QC discrepancy reports, action limit excursions, assay variances, and anomalous results reports for potential correlation to the respective batch history record.
Qualifications:
BS/BA or laboratory assistant in life sciences or equivalent.
2-5 year's pharmaceutical experience in manufacturing, quality assurance or quality control.
Lot review or batch release experience in biotech/pharmaceutical operations.
Must be capable of applying cGMP concepts and requirements to evaluate product disposition using sound judgment and decision-making skills.
Knowledge of cGMP's (Drugs and Biologics), and regulations applicable to U.S. and international Regulatory agencies.
Excellent communication skills, verbal, and written.
Languages:
Excellent in English and German, French would be desirable
Our client, a leading pharmaceutical organisation is currently seeking a Quality Assurance Specialist.
Location: Basel area
Duration: 6 month which might be extended
Start: ASAP
Job Duties/Responsibilities
The Quality Assurance Specialist will assist in the preparation of release packages for approval by the Manager of Lot Disposition and within established standard lead times. This work contains
review of batch records, deviation reports, chromatograms, batch reports and other quality records to support the lot release of commercial bulk products.
Report any issues, deviations, investigations or trends discovered during the lot review to Genentech quality management for review and approval per Genentech policies and procedures.
Work on other projects to support quality managers as needed in administrative work, Quality Risk Assessment, Audit tracking and closure, support of regulatory filings, commissioning, annual
product quality reviews, change control, metrics and other possible areas.
Interact on an ongoing basis with site quality managers to solve any quality issues.
Support the transport, storage and archiving of paper and/or electronic quality documents from the PTQXA manufacturing sites.
Technical Duties/Responsibilities:
Management of batch record review activities to ensure that products are dispositioned in accordance with regulatory requirements, cGMP's and Genentech/Roche policies and procedures, within standard lead times.
Interfacings with appropriate departments or manufacturing plants to ensure that lot disposition items are completed.
Notification to Senior Management for all known delays in meeting established standard lead times or any potential quality issues.
Interfacing with QA Lot Disposition Supervisors to ensure that final review activities are completed.
Performing a review of investigations for potential cumulative effect to a batch history record.
Performing a review of QC discrepancy reports, action limit excursions, assay variances, and anomalous results reports for potential correlation to the respective batch history record.
Qualifications:
BS/BA or laboratory assistant in life sciences or equivalent.
2-5 year's pharmaceutical experience in manufacturing, quality assurance or quality control.
Lot review or batch release experience in biotech/pharmaceutical operations.
Must be capable of applying cGMP concepts and requirements to evaluate product disposition using sound judgment and decision-making skills.
Knowledge of cGMP's (Drugs and Biologics), and regulations applicable to U.S. and international Regulatory agencies.
Excellent communication skills, verbal, and written.
Languages:
Excellent in English and German, French would be desirable
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Sonstiges