Computer System Validation-Pharmaceutical

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

Title: Computer Validation Specialist-PQM

Location: Fort Worth, TX

PharmEng Technology is a full service consulting firm that serves the pharmaceutical, medical devices and biotechnology industries in North America and internationally. Since 1997, the company has provided industry recognized consulting services assisting clients in the rapid commercialization of new product from drug discovery, strategic planning to process scale up. PharmEng has immediate opening for candidates with experience in Process Validation Engineer.

Essential Functions and Responsibilities

• Proficient in Validation and Qualification aspects of systems. If required, creates and documents Validation Plan, Quality Plan, IQ Report, OQ Report, and Validation Summary Reports.
• Drive continuous improvement of the quality system to meet and sustain compliance with internal and external regulatory requirements
• Conduct Quality reviews to evaluate if processes and deliverables fulfill the requirements for quality, to uncover errors or deficiencies in processes and deliverables, and to identify strengths and opportunities for improvement
• Follow up resolution of identified quality exposures and escalation to line management if critical situations are not resolved in due course
• Contribute to business decisions in the decisions in the definition and assessment of IT requirements
• Support the development and delivery of training in quality matters
• Drive and facilitate create of relevant of system SOPs.
• Prepare and follow internal authority inspections.
• Prepare, or review and approve major system documentation to ensure consistency with quality standards and quality deliverables.
• Coordination documentation, testing and change management activities to ensure compliance with business and regulatory needs
• Develop PQM resources for projects and services and monitor their performance to ensure adherence with agreed quality systems.
• Forecast demand and plan for IT PQM related to projects, provide task estimating and ICE roadmap to PMs, monitor and manage project risk and compliance
• Ownership IT CAPA and CCR Process for the responsible functional areas.

Minimum Qualifications:

• Bachelor's of Science and a minimum of 5 years experience in IT in pharmaceutical industry with expert knowledge of current regulations
• Ability to interact with all levels of the organization
• Influence and leadership capability, and credibility within the business
• Strong written and verbal communication skills
• Excellent written and spoken English

Thank you for your interest in our organization. However, only those selected will be contacted for an interview.