Senior Computerized System Validation (CSV) Specialist – Job Profile
IVY Works has an opening for full time employee as a Computerized System Validation Specialist or Engineer
Responsibilities
- Developing validation documentation for pharmaceutical 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 Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
Experience
- Bachelor's degree in engineering / science.
- 4-6 years of work experience is a must.
- 3+ years of 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.
- Project Management experience
Job Location
Our Office is located in Bangalore and the job may involve travel to client locations.
Computerized System Validation (CSV) Specialist – Job Profile
IVY Works has an opening for full time employee as a Computerized System Validation Specialist or Engineer.
Responsibilities
- Developing validation documentation for pharmaceutical 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 Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
Experience
- Bachelor's degree in engineering / science.
- 2-3 years of work experience is a must.
- 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.
Job Location
Our Office is located in Bangalore and the job may involve travel to client locations.
Senior Computerized System Validation (CSV) Specialist – Job Profile
IVY Works has an opening for full time employee as a Computerized System Validation Specialist or Engineer
Responsibilities
- Developing validation documentation for pharmaceutical 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 Process Automation, Laboratory Automation, Enterprise IT Applications and Network Infrastructure.
Experience
- Bachelor's degree in engineering / science.
- 4-6 years of work experience is a must.
- 3+ years of 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.
- Project Management experience
Job Location
Our Office is located in Bangalore and the job may involve travel to client locations.
Validation Specialist or Engineer– Job Profile
IVY Works has an opening for full time employee as a Validation Specialist or Engineer.
Responsibilities
- 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.
Experience
- Bachelor's 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.