Mid Senior Level Csv Professionals Job in Ivyworks

Mid Senior Level Csv Professionals

Ivyworks 4+ weeks ago

Ahmedabad, Gujarat
Not Disclosed
Full-time
Permanent

Apply Now

Save Job

Job Summary

Job Description

Roles and Responsibilities

1) Computerized System Validation (CSV) Associate or Analyst Job Profile:

The responsibilities will include developing validation documentation and support for computerized systems used in GLP, GMP and GCP environments. Validation documentation will encompass validation plans, specifications, test protocols and standard operation procedures. Systems may include Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.

Candidates are required to have at a minimum a bachelors degree in engineering / science.

1 - 6 years of work experience is a must.

Candidates must have experience/exposure to Computerized System Validation (CSV), US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.

Good communication and technical writing skills are a must.

2) Validation Specialist or Engineer Job Profile

Working on validation and compliance projects for clients. The projects will include developing validation documentation for pharmaceutical and biotechnology equipment, facilities and computerized systems used in GLP, GMP and GCP environments.

Project Deliverables will encompass validation plans, specifications, test protocols and standard operation procedures and systems may include Pharmaceutical and Biotech Manufacturing Equipment, Facilities, Utilities, and Process Automation.

Bachelors degree in engineering / science.

2-4 years of work experience is a must.

Experience/exposure to Equipment Validation, Facility Validation and GAMP 5.

Good communication and technical writing skills are a must.

Job Location

Our Office is located in Bangalore and the job may involve travel to client locations.

Role:Medical Writer

Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences

Functional Area:Research & Development

Role Category:Pharmaceutical & Biotechnology

Employment Type:Full Time, Permanent

Key Skillsdocumentation21 CFR PART IIcomputer system validationgmpvalidation

Education

UG:B.Pharma in Pharmacy,B.Tech/B.E. in Any Specialization

PG:Other Post Graduate

Doctorate:Other Doctorate

Company Profile

Ivy Works

IVYWORKS is a Compliance Consulting firm. We provide services to pharmaceutical and biotechnology industries. Visit http://www.ivyworks.net for more info.Company Info X View Contact Details+

Contact Company:Ivy Works

Website:http:// www.ivyworks.net

Experience Required :

1 to 6 Year

Vacancy :

2 - 4 Hires