Description
My Biotechnology client in South San Francisco is currently recruiting for a Senior Technical Manager, EQA position.Duties:
- Author or revise Quality Agreements supporting collaborations within Roche.
- Author or revise Product Specific Requirement documents supporting collaborations within Roche.
- Serve as project coordinator for process improvement initiatives.
- Compile and report out monthly data for Quality Issues at Contract Manufacturing sites.
- Prepare documentation for batch record review process and collaborate with Site Manager to complete batch assessments.
- Data entry in Development database.
- Data archival
All interested must have the required skill set and education requirements below:
- Provide review for Depot batch records.
- Provide assistance to Partners and Depots regarding quality inquiries.
- Establish work priorities to meet targets and timelines.
- Complete Destruction processing
- Gather all required documentation to support QP release activities at CMOs.
- Sound knowledge of cGMPs or equivalent regulations
- Ability to interpret and relate Quality standards for implementation and review
- Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
- Ability to communicate clearly and professionally both in writing and verbally
- Flexibility in problem solving, providing direction and work hours to meet business objectives
- Excellent written and verbal communication skills
- Strong interpersonal skills
Education Requirements:
- University degree, preferably in Life Sciences.
- Proven knowledge of GMPs, health authority regulations, and other international standards
- Demonstrated knowledge and execution of Quality operations and processes
- At least 3 years working experience in quality with experience in quality function in packaging operations
To find out more about Real please visit www.realstaffing.com