Pharma IT Validation Specialist – PQM Leader

PharmEng Nordic ApS; Fort Worth (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

PharmEng Technology is a full service consulting firm serving the pharmaceutical, medical devices and biotechnology industries in North America and internationally. An immediate opening is available for a Computer Validation Specialist-PQM to support IT QA and validation activities in Fort Worth, TX.

Responsibilities include creating validation documents, ensuring regulatory compliance, and coordinating testing, change control, and CAPA processes with cross-functional teams.

Qualifications

• Bachelor's of Science and at least 5 years IT experience in the pharmaceutical industry with regulatory knowledge.
• Ability to interact with all levels of the organization.
• Influence and leadership capability with business credibility.
• Strong written and verbal communication; excellent English.

Responsibilities

• Proficient in Validation and Qualification aspects of systems. Creates and documents Validation Plan, Quality Plan, IQ/OQ/Validation Summary Reports as needed.
• Drive continuous improvement of the quality system to meet regulatory requirements.
• Conduct quality reviews to evaluate processes and deliverables for quality and identify improvements.
• Follow up resolution of identified quality exposures and escalate if critical situations are not resolved.
• Coordinate IT requirements definition and assessment for projects.
• Support development and delivery of quality training.
• Prepare or review major system documentation to ensure quality deliverables.
• Coordinate testing and change management to ensure regulatory compliance.
• Develop PQM resources for projects and monitor performance.
• Forecast demand and plan for IT PQM related to projects; manage risk and compliance.

Skills

IT experience

Regulatory knowledge

Leadership

Communication skills

English proficiency

Education

Bachelor's degree in Science

Job description

PharmEng Technology is a full service consulting firm serving the pharmaceutical, medical devices and biotechnology industries in North America and internationally. An immediate opening is available for a Computer Validation Specialist-PQM to support IT QA and validation activities in Fort Worth, TX.

Responsibilities include creating validation documents, ensuring regulatory compliance, and coordinating testing, change control, and CAPA processes with cross-functional teams.