Validation Manager at QRC Group, Inc

Caguas, Puerto Rico, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Mar, 26

Salary

0.0

Posted On

13 Dec, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation Management, Pharmaceutical Manufacturing, Regulatory Compliance, Project Management, Analytical Skills, Problem-Solving, Communication Skills, cGMP Knowledge, FDA Guidelines, EMA Guidelines, ICH Guidelines, Cross-Functional Coordination, Risk Assessment, Change Control, Training, Documentation

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 The Validation Manager is responsible for overseeing and managing all validation activities within the pharmaceutical manufacturing facility. This includes equipment, utilities, processes, cleaning, and computerized systems to ensure compliance with regulatory requirements (FDA, EMA, ICH) and company standards. The role ensures that validation programs are effectively implemented, maintained, and continuously improved to support product quality and patient safety. Key Responsibilities: Develop, implement, and maintain the site validation master plan (VMP). Lead and manage validation projects for equipment, processes, cleaning, and computerized systems. Ensure compliance with current Good Manufacturing Practices (cGMP), regulatory guidelines, and internal policies. Review and approve validation protocols, reports, and related documentation. Coordinate with cross-functional teams (Engineering, Production, Quality Control, IT) to ensure timely execution of validation activities. Manage risk assessments and change control processes related to validation. Provide training and guidance to staff on validation principles and procedures. Support regulatory inspections and audits by providing validation documentation and expertise. Monitor and report validation progress, issues, and metrics to senior management. Qualifications Bachelor’s degree in Engineering or Sciences Minimum 5–7 years of experience in pharmaceutical validation or quality assurance. Strong knowledge of cGMP, FDA, EMA, and ICH guidelines. Experience with equipment, process, cleaning, and computer system validation. Excellent project management and leadership skills. Strong analytical, problem-solving, and communication abilities. Additional Information All your information will be kept confidential according to EEO guidelines.

Responsibilities

The Validation Manager oversees and manages all validation activities within the pharmaceutical manufacturing facility, ensuring compliance with regulatory requirements and company standards. This includes leading validation projects and coordinating with cross-functional teams to support product quality and patient safety.