QMS Technical Lead

Job Description

Must Have Technical/Functional Skills

• 10 – 12 years’ Sound experience with Trackwise - Configuration, Coordinator Configuration
• Crystal Reports Development and Web Services development required.
• Development experience on Trackwise Quality management software system Experience working with workflow configurations and resolving related issues when the records are stuck Experience working with PR Import Selection Worked on Trackwise Team Access Web Admin component.
• Perform troubleshooting and resolve L2 & L3 support issues such as record issues, workflow configuration issues, access issues, Perform regular support tasks such as PR import, Master data import, and creation of user access.
• Perform detailed data analysis, RCA, data validation and identify data quality issues and keep required stakeholders proactively informed on progress all support related activities and conduct regular ticket review analysis, suggest and implement continuous improvements.
• Candidate should have good understanding of interfaces connected with Trackwise (i.e. SFS, JDEL, ETL, SAP. etc).
• Candidate should have basic knowledge of Windows Server.
• Good technical knowledge in SQL, Trackwise DB structure and Crystal reports design
• Familiar with Business processes like Complaint, Deviation, Audit, CAPA etc.
• Good knowledge of Software Development Life Cycle, Change and Problem Management.
• Excellent English communication skills, both written and oral, additional languages would be a plus.
• GxP, 21 CFR Part 11, and Life sciences domain knowledge
• Actively participate in all the project related meetings and planning activities.

$120,000-$130,000 year

• Discretionary Annual Incentive.
• Comprehensive Medical Coverage:
  Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.
• Family Support:
  Maternal & Parental Leaves.
• Insurance Options:
  Auto & Home Insurance, Identity Theft Protection.
• Convenience & Professional Growth:
  Commuter Benefits & Certification & Training Reimbursement.
• Time Off:
  Vacation, Time Off, Sick Leave & Holidays.
• Legal & Financial Assistance:
  Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

BACHELOR OF COMPUTER SCIENCE