Job Details

Duration: 06 months contract
Shift: Regular working hours

Job Description:

• Computer Systems Validation experience is mandatory. Ability to interpret and apply GMP, GLP, and GCP regulations. Validation and change control experience is required. Strong documentation, operational, and guideline compliance experience. No specific degree requirement - candidates with extensive Computer Systems Validation experience are acceptable regardless of their degree field. Strong communication skills (written and verbal). A team player who can collaborate effectively. Ability to handle escalations professionally and de-escalate conflicts. Must be proactive and engaged, rather than just following procedures passively.

Duties:

• Act as Quality Assurance (QA) contact for Change Control(s) for Computerized System activities
• Review and Approve validation deliverables (e.g. Validation Plan, Requirement Assessment, support Testing Protocols, Summary Reports, etc.)
• Change Agent and advocate for the Risk Based Validation program
• Able to act as SME for multiple Quality processes (e.g. Deviations, CAPA)
• Review and Approve SOPs and associated documents
• Review/Approve Periodic Reviews for GxP Systems
• May perform software Supplier Evaluations as needed
• Support project initiatives, process improvements and or projects
• May be required to present on topics or issues to management
• May support audit & Inspections requests as needed
• May support other duties as required

Skills & Behaviors:

• Validation and Change Control experience (Highly preferred: Risk Based Validation experience and or strong Computer System Assurance (CSA) knowledge)
• Strong organizational skills, including ability to follow assignments through completion.
• Initiate and lead cross functional teams as needed
• Collaborate and communicate with higher level outside resources.
• Strong communication (both written and oral), facilitation, and presentation skills.
• Strong skill in working independently and to effectively interact with various levels of management
• Ability to lead and influence staff outside QA organization
• Able to manage performance issues and conflict
• Ability to evaluate documentation/ operations according to company and regulatory guidelines
• Ability to interpret and apply GMP, GLP, GCP, GPvP regulations

Preferred Qualification:

• 5+ years' experience in a regulated industries in a similar role (e.g. Biotechnology, Medical Device, Aerospace)
• Demonstrated strong Knowledge of industry and business principles
• Demonstrated strong problem-solving abilities and strong risk assessment capabilities

Nice-to-Have:

• Experience working with Veeva or Safety Systems is a plus, but not required.
• Knowledge of industry-wide regulatory systems

Education:

• Master's degree in technical or related subject and 3 years with directly experience
• Bachelor's degree in technical or related subject and 5 years with directly experience

Basic Qualifications:

• Doctorate degree OR
• Master degree and 3 years of experience OR
• Bachelor degree and 5 years of experience OR
• Associate degree and 10 years of experience OR
• High school diploma / GED and 12 years of experience

Must Have Skill Sets:

• Act as Quality Assurance (QA) contact for Change Control(s) for Computerized System activities
• Review and Approve validation deliverables (e.g. Validation Plan, Requirement Assessment, support Testing Protocols, Summary Reports, etc.)
• Change Agent and advocate for the Risk Based Validation program

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"