CSV VALIDATION ENGINEER

Please send the resumes to careers@starkassociatesllc.com or

Contact: +1 848-300-0022

Job Role : CSV Validation Engineer

Location : East Hanover,NJ

Duration : Long Term ( Work On Our W2 )

Job Description :

8-9 Years of Experience in computer system validation

Understanding of key Pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, SOX IT, Data Privacy, Data Integrity and Information Security

Subject matter expertise in areas such as Quality Management, document management and Change Management

Establish, implement and monitor the quality management requirements which assures that IT Projects meet Quality and Regulatory requirements

Knowledge of Risk management perform root cause analysis on trends and address deviations via preventive, detective and corrective measures

Knowledge and hands on experience conducting periodic or control maturity assessment and Audits

Knowledge of various Validation tools and templates used throughout the Pharmaceutical industry

Successful track record using Lean/Agile approaches to validate assets

Proven ability in handling multiple large projects, respond quickly to changing situations in complex environments

Experienced in leading strategic and tactical discussions with Senior stakeholders

Prior Alcon or Novartis experience is good to have.