Sign up with

Already have an account? Log in here

Need some help?
Talk to us at +91 7670800001

CSV Specialist at QRC Group, Inc

Caguas, Puerto Rico, United States -

Full Time

Start Date

Immediate

Expiry Date

24 Feb, 26

Salary

0.0

Posted On

26 Nov, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CSV Consulting, Technical Writing, GxP, Automation Impact Assessments, Standard Operating Procedures, Calibration, Preventive Maintenance, Project Communication, Documentation Control, Manufacturing Equipment, Regulated Industry, MS Office, Bilingual, Quality Assurance, Qualification Activities, Installation

Industry

Staffing and Recruiting

Description

Company Description QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions! Job Description CSV Specialist to support the installation of several manufacturing solid dosage equipment such as but not limited to: Encapsulator Checkweigher Compression machine Hardness tester Encapsulation machine Auxiliary equipment Main activities should include: Verification of the equipment installed and configured at the vendor site (FAT). Implement the progression from FAT through IOQ in accordance with the CC strategy. Installation at the manufacturing room for qualification activities. Qualification activities in the manufacturing room areas. Development of Standard Operating Procedures. Generation and routing of calibration and preventive maintenance forms. Development and approval of GxP and automation impact assessments. Provide alternatives to resolve documentation situations. Establish project communication and documentation controls. Assure consistent quality of activities that meets or exceeds the requirements. Qualifications Bachelor in Science or related field 2-3 years of experience as CSV consultant in regulated industry. Experience with MS Office applications (Word, Excel and MS Project) Excellent technical writing skills. Bilingual: English and Spanish, speaking and writing. Additional Information All your information will be kept confidential according to EEO guidelines.

Responsibilities

The CSV Specialist will support the installation and qualification of solid dosage manufacturing equipment. Key activities include verification of equipment, development of standard operating procedures, and ensuring quality compliance.