Hello,

Sunrise Systems Inc is an IT staff augmentation company and a direct 
vendor for various fortune 1000 clients. Kindly go through the following 
requirements and send me your resume in word format.
Please include your Candidate's complete name, location, availability, 
rate and contact  information in the body of the email along with word 
copy of the resume.

Please keep the subject line while responding to this email. If you have 
any more questions, feel free to give me a call.
Thanks!

--
Sincerely,
Dave Karlekar
Sunrise Systems
[EMAIL PROTECTED]
www.sunrisesys.com
732-603-2200 X-216
732-603-2208 (Fax)
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Job id - PZ30931QMCA 
Client - Pharma Company
Title - Quality Management & Compliance Analyst 
Location - La Jolla, CA (South California)
Duration - 6+ Months
Rate - Open

In-person Interview is REQUIRED

Quality Management and Compliance Analyst coming in from Pharma/Healthcare 
Domain. Responsibilities encompass all aspects of instrument services; 
maintenance, pm and calibration for Global Operations.

.       Setting up Quality Management, Change Management, Record Keeping, 
Compliance (GMP, GLP Systems)
.       Responsible for Compliance Program
.       GMP, Health Safety Compliance
.       Physical Inspection, Formalize & Create systems by writing SOP, Liaison 
with users (Scientists)
.       Hands on Role requiring Quality System and Quality Management System 
experience; preferably FDA or Health & System Management
GLP experience, Self Starter

.       Write SOPs needed to Compliance Quality Management, Calibration, system 
classification, and other regulatory requirements as needed.
.       Ensure Quality and Compliance (documentation) needs associated with 
Safety Equipment (e.g. Hydrogen Sensors), Histology, and LARC are met.
. Quality management, record keeping, document control experience is desirable. 
.       Record keeping and control including: SOP's, EOP's, Validations, 
Audits, Training, Calibrations, Inspections and Permits.  Includes 
documentation associated with Business Continuity Planning.
. Preferred 2 years experience working in a GXP environment.
. Knowledge of Health & Safety, as well as, statutory requirements of an 
engineering group is desirable.
. Prior experience as a technical writer is a plus.

May collaborate with QA Organizations (e.g. Pharm Sci QA, RQA, Global Audit)




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