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LIMS PROJECT MANAGER (CONTRACT) - 365362
LIMS PROJECT MANAGER (CONTRACT)
Biological / Scientific / Pharmaceutical / Medical Research
Wage / Salary:
R - Market Related - P/M (Per Month)
A pharmaceutical company based in the Midrand area has an exciting role for an experienced Laboratory Information Management System Project Manager who has 6 - 8 years of experience in information system in a laboratory setting.
The successful candidate will be responsible for creation and maintenance of LIMS masters. Preparing Packing, Raw materials, finished products and Stability test plans in accordance to approved specifications. Managing LIMS integration, administration, user support, user design, documentation, workflows and reports.
Qualifications and Experience:
Bachelor's degree in Chemistry/Computer Science/Management Information Systems
Minimum of 6 - 8 years of experience in information system in a laboratory setting
Working Knowledge of LIMS Labware system and coding of LIMs builds
Document Management, Data Entry, or technical writing experience
Experience with a Lab Information Management Systems
Experience managing next generation sequencing workflows through LIMS
Ability to communicate technical knowledge and escalate issues concerning impact
In-depth knowledge of laboratory technology solutions and state-of-the-art Lab practices
Strong interpersonal skills including influencing and aligning.
Strong critical thinking skills and the capacity to develop/implement solutions for complex needs
Strong laboratory informatics software and application (specifically LIMS) knowledge.
Providing in depth expertise and guidance to the Business and LIMS specialists in the use and adoption of the LIMS system
Provide support to all LIMS users including training and guidance on the use of the system.
Establish LIMS project priorities through communication with laboratory leadership
Create and manage project plans and timelines, define project deliverables, assign project team roles and resources, identify and track issues and their resolution, and
Creates and maintains LIMS system documentation
Manage performance of staff in accordance with the company's performance evaluation cycle
Participate in setting budgets for department and assigned projects
To ensure departmental expenditures within budget
Managing service delivery and budgetary requirements for assigned projects
System integration with existing systems as required by business needs
Draft, approve and follow relevant system software SOPs and policies
Initiate, author, review documents such as Change Controls, risk assessments, impact statements and corrective action plans
Lead investigations and root cause analysis for department issues of non-compliance
Develops User (SOP’s) and functional specifications/user roles
Provide guidance and direction to LIMS Specialists
Provide system oversight activities including audit trail reviews, system reviews, resolution of problem reports, data maintenance as required
Assist laboratory leadership in defining milestones for the completion of LIMS projects
Provide quality, timely, accurate LIMS analysis, design, configuration and support to LIMS users
Configure specifications, infrastructure, set-up, implementation, maintenance, validation, and troubleshooting software as per cGMPs, regulatory requirements and SOPs
Support system validation and qualification efforts
Ensure systems remain in compliant state
Process change control requests for system configurations, including design specifications, test plans, technical evaluation and quality risk assessments
Manage all projects related to LIMS implementation, maintenance/ enhancement
Compile metrics for Senior Management review
Design, develop and deploy improvements and extensions to the LIMS
Provide leadership to LIMS Specialists assigned to projects
Leading the team to implement, optimize and maintain LIMS
manage project scope, creep, and requirements
Creates and maintains configuration specifications for cGMP software for process control, monitoring and testing.