Γραφείο Διασύνδεσης & Σταδιοδρομίας - Specialist QA

Description

Amgen Job Description SUMMARY

This Job Description outlines the GMP job responsibilities for the Job Title and Job Code listed above.
This Job Description is to be used to document GMP responsibilities for key GMP personnel as required by GMP regulations.

FUNCTIONS

• Responsible for providing Quality oversight to ensure that operations for clinical and licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.
• Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations.
• Responsible for Quality disposition (approval or rejection) of raw materials and components, bulk drug substances, bulk drug products, and finished product for assigned areas
• Performs review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to Nonconformance's, CAPAs, and validations
• Supports Continual Improvement initiatives, programs and projects
• Ensures that changes that could potentially impact product quality are assessed according to procedures
• Ensures that deviations from established procedures are investigated and documented per procedures
• Ensures that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
• Collaborates cross functionally as needed to ensure the Quality Management System processes are executed in accordance with established procedures
• Alerts senior management of quality, compliance, supply and safety risks
• Represents the quality unit during audits and inspections as needed
• Supports internal/external audits and inspections as part of the audit/inspection management team as needed
• Completes required assigned training to permit execution of required tasks
• Performs additional duties as specified by management
• Other functions may be assigned
Basic Qualifications • Doctor degree in Science or Engineering
OR
• Master's degree in Science or Engineering and 3 years of Quality experience in pharmaceutical, medical device or biotechnology industry
OR
• Bachelor's degree in Science or Engineering and 5 years of Quality experience in pharmaceutical, medical device or biotechnology industry
Preferred Qualifications PREFERRED QUALIFICATION
• Project management skills
• Strong organizational skills, including ability to follow assignments through to completion
• Initiate and lead cross functional teams
• Enhanced skills in leading, influencing and negotiating
• Strong knowledge in area of expertise
• Collaborate and coordinate with higher level outside resources
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation...