GMP Quality Systems and Compliance Manager

3 months ago


Novato, United States Intelliswift Software Full time

Job Description:

Title: Quality System Manager

Location: Novato, CA

Duration: 12 Months on W2


Summary Description

The Quality Systems Technical Manager is responsible for ensuring ***’s Quality Systems, such as Documentation, Deviation, CAPA, Change Control, Self-Inspection, and Risk Management are consistently administered and followed.


Responsibilities:

Participate in inspection readiness, regulatory inspection support and self- inspection activities.

Quality system metrics and trending.

Works cross functionally with management within and outside Technical Operations to ensure consistency of use of the quality systems.

Participate in quality system improvement and process mapping initiatives.

Author and own site Quality Technical Agreements.


Education:

BS/MS preferably in the life sciences


Experience:

6+ years’ experience in pharmaceutical or related industry.

Demonstrated knowledge of cGMPs, Health Authority Regulations, Quality Systems and technical expertise in manufacturing processes.

Ability to comprehend technical information related to analytical methods, manufacturing processes and regulatory expectations.



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