Principal Consultant - Pharma
Basic Qualifications :
- B.S. in Software, or MS in engineering discipline
- Minimum 10 years of experience in Pharma and Life Sciences
- Exposure to LIMS, Regulatory, Sound Clinical depth, experience with Mobile, Cloud desirable
- Conversant with Pharma standards and regulatory requirements like IEC, CE, UL, IP
- Minimum 5 years in experience with LIMS concepts such as experiment, component, compound, product, sample, batch, lot etc.
- Minimum 5 years in experience in protocol management, LIMS reports such as Crystal reports, Stability reports, EM Summary reports etc.
- Exposure to LIMS Basic language, subroutines, debugging
- Understanding of network architecture, Application servers, Oracle database, SMTP servers
- Good written and oral communication skills
- Desire to work in a management consulting environment that requires regular travel
- Ability to effectively lead projects or project elements in a cross functional teaming environment.
- Proven ability to work independently with minimal oversight and complete tasks within scheduled milestones
- Good problem solving skills, strong time management skills, strong team work and multi-tasking skills
Desired/Preferred Qualifications :
- Prior work in the release of medical products in a regulated environment (knowledge of FDA regulations / Design Controls)
- LabWare certification for LIMS Administration 1 and 2
- Passionate about making innovations.
- 10+ years Technical leadership
- Experience with a successful track record in releasing products to market
- Knowledge and experience using DRM/DFSS/Six Sigma is a plus
Roles/Responsibilities :
As a Principal Consultant :
- Draft the value-adding consulting solutions that enable Clients to meet the business needs
- Contribute to different phases of the consulting lifecycle; define the problem/objective, propose and create the solution
- Own the development, configuration and deployment of the overall solution
- Develop functional IT requirements and specifications for new or upgraded software applications
- Guide the teams on project processes, deliverables and help detail the project scope.
- Contribute to the proposal development, client training and internal capability building
- Lead the process scoping, designing, configuring and validating the LIMS.
- Coordinate the integration of laboratory instrumentation with the LIMS
- Review validation documentation, validation scripts and change control processes
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