What are the responsibilities and job description for the CSV Consultant position at LTIMindtree?
Role Description
Strong knowledge of Pharmaceutical Laboratory systems CSV covering the complete lifecycle including Requirements gathering SLRA Validation plan Specifications DS FS CS Functional Risk assessment IQ OQ PQ Validation report and Trace matrix
Understanding of pharmaceutical network Infrastructure layers and its qualification Data center and all relevant network equipment including monitoring tools servers routers firewalls network switches cabling and end access Points
Experience in Spreadsheets qualification Categorization IQ OQ
Experience in validation of Laboratory Information management Systems LabVantage
Hands on experience with ValGenesis validation tool
Raising an ITCR with proper description reason for change implementation plan impact assessment and other requirements per customers SOP
Reviewing and verify execution of ITCR Monitoring ITCR 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
Raising deviation processing investigation causal analysis implementation efficacy closure and other requirements per customers SOP
Raising an IT CAPA initiation action processing root cause analysis
Monitoring deviations and CAPAs for extension amendment approval and closure
CreateReview requirements specification for compliance with the applicable regulatory requirements
Knowledge of Patch management
Write review evaluate the configuration management plans and procedures associated with the development process
Conduct postimplementation periodic review of systems
Skills
Mandatory Skills : Regulatory & Compliance - Computer system validation
Other Details
Benefits/perks listed below may vary depending on the nature of your employment with LTIMindtree (“LTIM”):
Benefits And Perks
Disclaimer: The compensation and benefits information provided herein is accurate as of the date of this posting.
LTIMindtree is an equal opportunity employer that is committed to diversity in the workplace. Our employment decisions are made without regard to race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), gender identity or expression, national origin, ancestry, age, family-care status, veteran status, marital status, civil union status, domestic partnership status, military service, handicap or disability or history of handicap or disability, genetic information, atypical hereditary cellular or blood trait, union affiliation, affectional or sexual orientation or preference, or any other characteristic protected by applicable federal, state, or local law, except where such considerations are bona fide occupational qualifications permitted by law.
Benefits
Compensation range: $ 110,000.00 to 130,000.00 per year
Strong knowledge of Pharmaceutical Laboratory systems CSV covering the complete lifecycle including Requirements gathering SLRA Validation plan Specifications DS FS CS Functional Risk assessment IQ OQ PQ Validation report and Trace matrix
Understanding of pharmaceutical network Infrastructure layers and its qualification Data center and all relevant network equipment including monitoring tools servers routers firewalls network switches cabling and end access Points
Experience in Spreadsheets qualification Categorization IQ OQ
Experience in validation of Laboratory Information management Systems LabVantage
Hands on experience with ValGenesis validation tool
Raising an ITCR with proper description reason for change implementation plan impact assessment and other requirements per customers SOP
Reviewing and verify execution of ITCR Monitoring ITCR 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
Raising deviation processing investigation causal analysis implementation efficacy closure and other requirements per customers SOP
Raising an IT CAPA initiation action processing root cause analysis
Monitoring deviations and CAPAs for extension amendment approval and closure
CreateReview requirements specification for compliance with the applicable regulatory requirements
Knowledge of Patch management
Write review evaluate the configuration management plans and procedures associated with the development process
Conduct postimplementation periodic review of systems
Skills
Mandatory Skills : Regulatory & Compliance - Computer system validation
Other Details
Benefits/perks listed below may vary depending on the nature of your employment with LTIMindtree (“LTIM”):
Benefits And Perks
- 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
Disclaimer: The compensation and benefits information provided herein is accurate as of the date of this posting.
LTIMindtree is an equal opportunity employer that is committed to diversity in the workplace. Our employment decisions are made without regard to race, color, creed, religion, sex (including pregnancy, childbirth or related medical conditions), gender identity or expression, national origin, ancestry, age, family-care status, veteran status, marital status, civil union status, domestic partnership status, military service, handicap or disability or history of handicap or disability, genetic information, atypical hereditary cellular or blood trait, union affiliation, affectional or sexual orientation or preference, or any other characteristic protected by applicable federal, state, or local law, except where such considerations are bona fide occupational qualifications permitted by law.
Benefits
Compensation range: $ 110,000.00 to 130,000.00 per year
Salary : $110,000 - $130,000