11/09 Si2Tech
IT Head at Si2 Technologies

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Si2 Technologies - Computer Systems Validation Analyst (3-6 yrs)

Vadodara/Baroda Job Code: 490965

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

c. GHTF/SG3/N99-10-2004

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.

Women-friendly workplace:

Maternity and Paternity Benefits

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