Senior Track Lead

Job Summary

Computerized System Validation (CSV)

Job Roles/Responsibilities:

• Act as Validation and Qualification Lead on a large laboratory remediation projects, with specific focus on Laboratory Standalone COTS systems
• Author the typical validation, qualification, and testing documentation such as Validation Plans/Summaries, Test Plans/Summaries, User Requirements, Configuration Specifications, Trace Matrix, Qualification Protocols (IQ/OQ/PQ) and Scripts, Testing Defects, etc.
• Assist systems users with defining, authoring and documenting system use in user, admin, and maintenance SOPs
• Coordinate alignment of systems users from various company groups on validation and qualification documentation
• Proactively communicate with various company organizations and systems vendors to ensure the project hurdles are overcome quickly and effectively
• Provide tactical guidance and coaching in support of systems testing efforts with the stakeholders
• Act as validation task lead: take ownership of related tasks, work under minimal supervision, utilize the industry experience and best judgment to make tactical decisions, stay proactive, etc.
• Support the review & approval of key quality deliverables including SDLC, Change control, Deviations, CAPAs. Etc.
  Attend periodic review meetings, cutover migration, hyper care support, any enhancements planning, design and/or implementation meetings as required.
• Good at customer handling and liaising with all stakeholders.

Qualifications & Education:

• 5+ years of Lab Systems validation experience is required.
• Specific hands-on experience with validating, qualifying, and/or using Pharmaceutical QC Lab Standalone COTS systems are required, including the authoring end to end of life cycle documents (including systems use and administration procedures)
• Understanding of Data Integrity concepts is required
• Excellent communication and written skills required
• You have strong analytical skills and an aptitude for decision-making
• You show resilience when faced with challenges
• You believe in continuous learning and growth

Key Responsibilities

1. To monitor and track tickets/change requests and manage SLAs.
2. To work towards continuous improvement , perform root cause analysis and act as a point of escalation for complex and high-priority customer issues, ensuring timely resolution and maintaining high levels of customer satisfaction.
3. To prepare and submit status reports for minimizing exposure and risks on the project or closure of escalations
4. To develop and guide the team members in enhancing their technical capabilities and increasing productivity

Skill Requirements

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Other Requirements

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