:
SUPPORT INSTALLATION AND QUALIFICATION OF LAB SYSTEMS
Core Job
DUTIES:
* Commissioning, Qualification, and Validation of many different
types of lab instrumentation and equipment
* Technical contribution for Qualification and Validation Documents
(e.g. Risk Assessment, Validation Plan, Design
Configuration/Specification, User
_REQUIREMENTS_ , Functional
_REQUIREMENTS_ , IQ OQ PQ, Trace Matrix, Validation Summary Report),
SOPs, Maintenance Procedures, Calibration Procedures, and other
instrument support documents
* Provide support for the translation of technical information and
requirements into qualification/validation test design
* Escort and coordinate with instrument vendor service engineers and
review vendor qualification documentation
* Contribute to the overall growth of Perkin
Elmer?s compliance business
_QUALIFICATIONS_ , Skills &
EXPERIENCE:
* Bachelor?s Degree; scientific background preferred
* At least **Apply on the website** years of pharmaceutical of FDA
related validation experience
* Good knowledge of GMPs, **Apply on the website**
CFR Part **Apply on the website**, USP **Apply on the website**, GAMP
5 ? and other relevant industry regulations and guidance
* Strong interpersonal skills and demonstrated ability work
independently
* Organized and task oriented
* Excellent written and oral communication skills ? especially on
technical topics
* Self-directed and motivated individual who is able to operate in a
rapidly changing business environment
* Customer-oriented, conducting job function with a primary focus on
customer satisfaction (internal & external) and ability to deal with
customer complaints
*
_MUST HAVE_ a strong command of Microsoft Office Word and Excel and
Adobe Acrobat, Microsoft Project
*
_ABILITY TO_ Build consensus among team of stakeholders
* Excellent critical thinking/analytical and problem solving skills
*
_EXPERIENCE WITH_ a multitude of laboratory equipment a plus
Work
CONDITIONS:
Lab Environment (may need to follow Personal Protective Equipment and
Safety Polices);
Office Environment.
PURPOSE
:
SUPPORT INSTALLATION AND QUALIFICATION OF LAB SYSTEMS
Core Job
DUTIES:
* Commissioning, Qualification, and Validation of many different
types of lab instrumentation and equipment
* Technical contribution for Qualification and Validation Documents
(e.g. Risk Assessment, Validation Plan, Design
Configuration/Specification, User
_REQUIREMENTS_ , Functional
_REQUIREMENTS_ , IQ OQ PQ, Trace Matrix, Validation Summary Report),
SOPs, Maintenance Procedures, Calibration Procedures, and other
instrument support documents
* Provide support for the translation of technical information and
requirements into qualification/validation test design
* Escort and coordinate with instrument vendor service engineers and
review vendor qualification documentation
* Contribute to the overall growth of Perkin
Elmer?s compliance business
_QUALIFICATIONS_ , Skills &
EXPERIENCE:
* Bachelor?s Degree; scientific background preferred
* At least **Apply on the website** years of pharmaceutical of FDA
related validation experience
* Good knowledge of GMPs, **Apply on the website**
CFR Part **Apply on the website**, USP **Apply on the website**, GAMP
5 ? and other relevant industry regulations and guidance
* Strong interpersonal skills and demonstrated ability work
independently
* Organized and task oriented
* Excellent written and oral communication skills ? especially on
technical topics
* Self-directed and motivated individual who is able to operate in a
rapidly changing business environment
* Customer-oriented, conducting job function with a primary focus on
customer satisfaction (internal & external) and ability to deal with
customer complaints
*
_MUST HAVE_ a strong command of Microsoft Office Word and Excel and
Adobe Acrobat, Microsoft Project
*
_ABILITY TO_ Build consensus among team of stakeholders
* Excellent critical thinking/analytical and problem solving skills
*
_EXPERIENCE WITH_ a multitude of laboratory equipment a plus
Work
CONDITIONS:
Lab Environment (may need to follow Personal Protective Equipment and
Safety Polices);
Office Environment.
We need : English (Good)
Type: Permanent
Payment:
Category: Others
