Senior Specialist - Consulting

Responsibilities

• Strong knowledge of Pharmaceutical QMS Laboratory systems covering the complete lifecycle
• Knowledge of handling Veeva Deviations and CAPA Raising
• Deviation processing investigation, causal analysis, implementation, efficacy closure and other requirements per customers SOP
• Raising an ITCR in ServiceNow with proper description, reason for change, implementation plan, impact assessment and other requirements per customers SOP
• Raising an IT CAPA and processing root cause analysis
• Monitoring deviations and CAPAs for extension, amendment approval and closure
• Experience in validation of Laboratory Systems
• Hands-on experience with ValGenesis validation tool
• ITCR Monitoring through closure
• Good understanding of 21 CFR Part 11 and GAMP 5 and other GxP standards
• Drafting and execution of qualification protocols
• User access review
• Create and Review requirements specification for compliance with the applicable regulatory requirements
• Knowledge of Patch management
• Conduct post-implementation periodic review of systems

Qualifications

Actual compensation within the range will be dependent upon the individual's skills, experience, performance and internal equity.

Benefits

• Comprehensive Medical Plan Covering Medical, Dental, Vision
• Short Term and Long-Term Disability Coverage
• 401(k) Plan with Company match
• Life Insurance
• Vacation Time, Sick Leave, Paid Holidays
• Paid Paternity and Maternity Leave

Schedule

The range displayed on each job posting reflects the minimum and maximum salary target for the position across all US locations. Within the range, individual pay is determined by work location and job level and additional factors including job-related skills, experience, and relevant education or training.

Pay

Depending on the position offered, other forms of compensation may be provided as part of overall compensation like an annual performance-based bonus, sales incentive pay and other forms of bonus or variable compensation.