Job Number: 20-07186
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Validation Specialist for our client in Princeton, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- This role will focus on the facilitation and execution of data integrity (DI) assessment and remediation activities for enterprise GxP systems in support of the Client Data Integrity Governance Program.
- This role will be accountable for ensuring the required activities are complete according to an approved Enterprise Systems DI Compliance Plan and that DI requirements are addressed thoroughly and effectively in a timely manner.
- Effective communication is key across a multi-functional team consisting of Business, IT, and Quality personnel.
- Knowledge of DI and Client principles is desired, but a strong Computerized System Validation (CSV) background with proven ability to interpret and implement 21CFR Part 11 requirements is sufficient.
- Facilitate the Data Integrity Assessment to identify DI gaps that require remediation in the form of technical and/or procedural controls.
- Maintain close communication with stakeholders and team members to keep apprised of DI needs, interpretation of DI requirements, impacts on DI compliance of an application, DI project status, and other relevant DI issues
- Create documents to an existing document standard, including but not limited to DI Assessments, DI Remediation Plans/Summaries, Data Flow Risk Assessments including excel-based Failure Mode & Effects Analysis (FMEA)
- Obtain and respond to review by Business, IT, and Quality stakeholders
- Apply FDA, MHRA, and other applicable global health authority CSV and DI regulations/requirements to the development of computer systems supporting regulated business processes
- Follow SOPs and industry best practices
- 6+ years’ experience in Pharmaceutical/Biotech industry supporting CSV/SDLC activities in a GxP regulated environment
- 1+ year experience with Data Integrity assessment/remediation activities
- Cross-functional experience with enterprise-level applications in one or more regulated areas (i.e. Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is desired.
- Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes.
- Able to write clear and technically sound GxP regulated documentation able to satisfy quality assurance expectations and audits/inspections.
- Advanced knowledge of complete MS Office suite and Visio.
- Firm understanding of technology platforms as needed for project.
- Experience with electronic document management systems (e.g. Qumas, SharePoint etc.); application development and lifecycle management (e.g. Client ALM, JIRA, etc.); and IT service management systems (e.g. ServiceNow)
- Excellent oral and written communication skills in English.
- Strong expertise and ability to interview and accurately interpret communication requirements of team members.
- Once trained, have the ability to work independently on DI projects with minimal oversight.
- Demonstrate the ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives.
- Demonstrate strong leadership capability with ability to make and act on decisions while balancing speed, quality and risk.
- Able to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
- Excellent interpersonal skills, including written and verbal communication.
- Strong sense of ethics, diplomacy and discretion.
- Commitment to quality.
- Strong critical thinking to analyze complex situations and discern critical issues.
- Able to work effectively with highly-matrixed and multi-cultural workforce and build strong relationships by being transparent, reliable and delivering on commitments.
- Excellent team player attitude.
- Able to manage competing priorities.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.