What are the responsibilities and job description for the Compliance Lead (QMS implementation) position at Vakula Technologies Inc?
Job Role - Compliance Lead (QMS implementation).
Location - KOP, PA (Hybrid).
Contract: 6 Months.
Experince: 6-8 Years.
Except CPT & OPT.
Pay Rate: $45-48/hr on W2.
Essential Skills: QMS Implementation, Regulatory Knowledge (GxP,GAMP5), Risk Management, CAPA.
Job Description
Experience in QMS implementation
Hands on experience in: Application Periodic Reviews , Risk Management GAMP5 guidelines GxP processes Supplier Assessments Training Management Metrics Management Configuration Management (CMDB Doc Control) Process implementation experience in SDLC environment.
Good experience in external and internal regulatory audit management
Hands on experience in CAPA and Process Improvements.
Qualification- Minimum requirement is a bachelor s degree in computer science, Sciences or a related education (e.g. life science, medicine) , master's preferable.
Location - KOP, PA (Hybrid).
Contract: 6 Months.
Experince: 6-8 Years.
Except CPT & OPT.
Pay Rate: $45-48/hr on W2.
Essential Skills: QMS Implementation, Regulatory Knowledge (GxP,GAMP5), Risk Management, CAPA.
Job Description
Experience in QMS implementation
Hands on experience in: Application Periodic Reviews , Risk Management GAMP5 guidelines GxP processes Supplier Assessments Training Management Metrics Management Configuration Management (CMDB Doc Control) Process implementation experience in SDLC environment.
Good experience in external and internal regulatory audit management
Hands on experience in CAPA and Process Improvements.
Qualification- Minimum requirement is a bachelor s degree in computer science, Sciences or a related education (e.g. life science, medicine) , master's preferable.
- To be responsible for providing technical guidance to a team of developers, enhancing their technical capabilities and increasing productivity.
- To conduct comprehensive code reviews, establish and oversee quality assurance processes, performance optimization , implementation of best practices and coding standards to ensure successful delivery of complex projects.
- To ensure process compliance in the assigned module, and participate in technical discussions or review as a technical consultant for feasibility study (technical alternatives, best packages, supporting architecture best practices, technical risks, breakdown into components, estimations).
- To collaborate with stakeholders to define project scope, objectives, deliverables and accordingly prepare and submit status reports for minimizing exposure and closure of escalations.
Salary : $45 - $48
