Si2 Technologies - Computer Systems Validation Analyst (3-6 yrs)
SKILLS REQUIRED :
- Can read and understand procedures and regulations;
- Can comprehensively analyse data;
- Can present information properly in communication (i.e. written, verbal)
Write and/or manage others in the preparation of C/Q/V documents aligned with established standards and templates, including but not limited to the following :
a. C/Q/V Master Plans
b. Commissioning Forms
c. C/Q/V Protocols and Summary Reports
d. Standard Operating Procedures
e. Impact Assessments
f. Specifications (URS/FRS/DDS)
Experience working in a regulated environment for the Biotech, Pharmaceutical, or Medical Device Industries, prior experience of the following Regulations and Standards :
a. 21CFR Parts 11, 210, 211, and 820
b. US FDA CDER 2011
d. EU Guidelines for Good Manufacturing Process for Medical Products for Human and Veterinary Use, Annex 15: Qualification and Validation
e. ICH Guidelines for Industry Q7 Good Manufacturing Practices for Active Pharmaceutical Ingredients
f. ASTM E2500
g. GAMP 5.
PROFESSIONAL REQUIREMENTS :
- 3+ yrs work experience in a regulated environment for the Biotech, Pharmaceutical, or Medical Device Industries
- Strong knowledge of Business Processes
- Knowledge on Various Inspection processes in Procurement, Production & Sales.
- Should have good written & communication skills with Fluency in English.
- Should independently be able to handle the requirements.