David Brewer is a skilled professional, who works in Sequence, Inc as a Senior Manager, Quality & Compliance since 2003. This expert has earned professional experience in more than ten positions at different companies. David Brewer went to the East Carolina University and got education from 1993 to 1999. Raleigh, North Carolina is the city, where the professional was known to be settled. This expert's email address and phone are easily accessed through this website on demand.
Name variants:
Daved Brewer,
Dayvid Brewer,
Dave Brewer,
Davey Brewer,
Davie Brewer,
Davy Brewer
Last updated Apr 29, 2024
Contact Information
Last Update
Feb 1, 2016
Location
Raleigh, NC
Company
Sequence, Inc.
Workplace
Senior Manager, Quality & Compliance
Work History
Senior Manager, Quality & Compliance
Raleigh-Durham, North Carolina Area
Sequence, Inc. is a leader in providing validation and quality/compliance consulting services for industries regulated by the FDA. United with our Clients, we provide consumers with products...
from Dec 2003
Overall Validation Project Manager on behalf of Sequence, Inc.
Winston-Salem, NC
Providing guidance for implementation of corporate-wide Quality system. Creating Policies/SOPs. Interpreting FDA regulations, legislation and guidance documents for the Client. Validation le...
from Apr 2011
Senior Validation Consultant and Site Lead on behalf of Sequence, Inc.
Clayton, North Carolina
Served as the Site Lead for Sequence, Inc. staff on-site. Validation lead for Electronic Drawing Mgmt System, Learning Management System and TrackWise implementation/upgrade projects.
Dec 2009 — Apr 2011
Senior Validation Consultant on behalf of Sequence, Inc.
Sanford, North Carolina
Generated deliverables (GxP/Part 11 Assessment, Risk Assessment, URS, Validation Plan, Trace Matrix, IOQ, PQ, & Validation Summary Reports) for validation of various analytical instrumen...
Jul 2005 — Nov 2009
Senior Validation Consultant on behalf of Sequence, Inc.
Clayton, North Carolina
Validation lead for the SAP Separation of Plasma business from Bayer HealthCare SAP system. Reviewed and approved validation-related documents per Client, FDA, and cGMP guidelines.
Wrote ...
Dec 2004 — Apr 2005
Senior Validation Consultant on behalf of Sequence, Inc.
Montreal, Canada Area
Validation Representative for QC & ML-21 Suite remediation effort. Worked with Area Management to fulfill Validation Master Plan. Reviewed/Approved Val. docs. Evaluated SOPs & assist...
Aug 2004 — Dec 2004
Validation Consultant on behalf of Sequence, Inc.
Greenville, North Carolina Area
Assisted with the validation effort for the SAP R/3 implementation. Lead the data conversion & verification effort. Validation Rep. for the decommissioning of the legacy mainframe system...
Dec 2003 — Jun 2004
Computer Validation Specialist
Human Genome Sciences, Inc. & MedImmune (Rockville & Gaithersburg, MD)
Developed/Executed IQ/OQ/PQ protocols for a Bioreactor & Air Compressor system and wrote reports to summari...
Sep 2003 — Dec 2003
Senior Validation Specialist
Indiana Protein Technologies, Inc. (Greenwood, IN)
Developed IQ/OQ/PQ protocols for WFI and USP PW systems per Client, FDA, and cGMP guidelines.
Wyeth (Carolina, Puerto Rico)
Executed Comput...
Oct 2000 — Aug 2003
Computer Validation Technician
Contracted to Catalytica Pharmaceuticals, Inc. (Greenville, NC)
Assessed systems for 21 CFR Part 11 compliance
Planned, organized, and conducted validation activities per current validation ...
Jun 1999 — Oct 2000
Education
1993 — 1999
Occupations
Executive
Senior Manager
Project Manager
Leader
Operations Manager
Project Managers
Managers
Skills
Compliance
Biotechnology
Quality
Quality Systems
Computer System Validation
Change Control
SDLC
21 CFR Part 11
cGMP
testing
Quality Assurance
FDA
Change Management
Pharmaceuticals
Biopharmaceuticals
Document Management
Procedure Development
SOP
Auditing
Sop
Testing
GMP
Validation
Software Documentation
V&V
Pharmaceutical Industry
Quality System
GxP
LIMS
SAP
Automation
CAPA
Trackwise
Calibration
GAMP
Aseptic Processing
Cleaning Validation
Technology Transfer
GLP
FAQs about David Brewer
What is the main profession of David Brewer?
This professional's job is Senior Manager, Quality & Compliance
What jobs is David a professional at?
The expert is proficient at Executive and Senior Manager jobs.
Where does David Brewer live?
Raleigh, North Carolina is the place where David Brewer lives
Where did David Brewer work?
David Brewer worked at Sequence, Inc., RAI Services Company.
What education does David Brewer have?
David studied at the East Carolina University from 1993 to 1999.
What is professional industry that David Brewer is connected to?
This professional works in Pharmaceuticals industry.
Are there any special skills, that David Brewer has?
David Brewer has the following skills: Compliance, Biotechnology, Quality, Quality Systems, Computer System Validation, Change Control, SDLC, 21 CFR Part 11, cGMP, testing, Quality Assurance, and FDA.