Validation/Test Lead
Apply NowCompany: SysMind Tech
Location: Boston, MA 02115
Description:
Relevant Experience
(in Yrs)
10 + years
Technical/Functional Skills
Validation/Test hands on in manufacturing/lab systems in pharma companies. Experience in Waters Empower system
Experience Required
Overall IT Experience: 10 years +
Validation Lead/Test Experience: 5 years +
Tools sets experience:
Micro Focus ALM (HP ALM)
MS Office tools set
Must have Experience:
Should have solid validation lead experience working for pharmaceutical companies as Val lead.
Should have great communication and coordination skills between internal team and customers across shores.
Should have good track record in managing teams to successful project delivery.
Should have solid experience in creating/executing best practices, guidelines, checklist GxP projects execution.
Worked in Life Sciences vertical both GxP and non GxP space.
Familiar with Life science business process flow.
Should have good understanding and experience on execution and managing GxP projects and deliverables.
Experience in systems like Waters Empower(Must), LIMS, MES, etc will help.
Roles & Responsibilities
As a hands on Val/Test lead is responsible for end to end validation and testing deliverables following Computer System Validation life cycle and also author, review, approve GxP/Risk Assessment, Val Plan, IQ, OQ, PQ, Val Summary, Traceability matrix, URS, FRS, Design documents
(in Yrs)
10 + years
Technical/Functional Skills
Validation/Test hands on in manufacturing/lab systems in pharma companies. Experience in Waters Empower system
Experience Required
Overall IT Experience: 10 years +
Validation Lead/Test Experience: 5 years +
Tools sets experience:
Micro Focus ALM (HP ALM)
MS Office tools set
Must have Experience:
Should have solid validation lead experience working for pharmaceutical companies as Val lead.
Should have great communication and coordination skills between internal team and customers across shores.
Should have good track record in managing teams to successful project delivery.
Should have solid experience in creating/executing best practices, guidelines, checklist GxP projects execution.
Worked in Life Sciences vertical both GxP and non GxP space.
Familiar with Life science business process flow.
Should have good understanding and experience on execution and managing GxP projects and deliverables.
Experience in systems like Waters Empower(Must), LIMS, MES, etc will help.
Roles & Responsibilities
As a hands on Val/Test lead is responsible for end to end validation and testing deliverables following Computer System Validation life cycle and also author, review, approve GxP/Risk Assessment, Val Plan, IQ, OQ, PQ, Val Summary, Traceability matrix, URS, FRS, Design documents