Validation Manager at QRC Group, Inc

Canóvanas, Puerto Rico, United States -

Full Time

Start Date

Immediate

Expiry Date

23 Feb, 26

Salary

0.0

Posted On

25 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Validation Management, Project Management, cGMP Knowledge, Regulatory Compliance, Analytical Skills, Problem-Solving, Communication Skills, Leadership Skills, Risk Assessment, Change Control, Training, Documentation, Cross-Functional Coordination, Quality Assurance, Pharmaceutical Industry Knowledge, Computer System Validation

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. This includes ensuring compliance with regulatory requirements and maintaining validation programs to support product quality and patient safety.