Project Management
- Align with management and via P&PR meeting to identify potential capital requirements. Develop and maintain capital plan, including projects driven by new requirements or re-capitalisation
- Lead initial Capital Acquisition Requests (CARs), liaising with suppliers and relevant parties to establish business case
- Develop project plan and identify key milestones, confirming timelines meet sponsor鈥檚 need and confirming resource availability with resource owners (QC/ IT etc)
- Oversee purchasing and installation of new equipment and hand-over to instrument responsible person
- Integrate project into governance process (e.g. daily Tier 2, weekly PMA meeting, S&OP). Report progress and lead to ensure project timelines, budget and requirements are met. Implement / coordinate new projects ensuring compliance to cGMP, sustainability and safety requirements, as well as end user needs
- Identify, evaluate, drive and or lead (as appropriate) continuous improvement initiatives and lab-related projects where significant change can be made in terms of cost, supply, quality, compliance, safety etc.
- Track own time and provide to finance
- Ensure appropriate capitalisation of assets and reporting of capital spend. Act as a single point of contact for the finance department on capital related items
- Complete post review of projects, summarising lessons learned, whether CAR requirements were met
- Point of contact for any issues arising after completion of projects
Equipment/ Computer Systems Validation
- Write and own change control for new equipment introduction
- Write, review or approve computer system and equipment validation documents, such as user requirement specifications, qualification protocols and reports
- Co-ordinate with IT to ensure completion of risk assessments, design specifications, Electronic Record/ Signatures assessments, IT IQ/OQ, Privilege Lists, system admin SOP are completed for new equipment software applications, ensuring data integrity requirements are met
- Co-ordinate with vendor for completion of IQ/OQ activity
- Liaise with QC for development and execution of PQ and operating SOP. Liaise with trainers to ensure a training plan is in place for new equipment
- Ensure all new equipment software applications are added to CSV inventory
Other
- Use best practice and knowledge of internal and external issues to improve service and processes
- Look beyond ISL to define and resolve complex issues - Benchmark and liaise with other SGS labs to enhance performance
- Liaise with Site Services/ Global groups on equipment shutdown planning
- Business continuity SPOC for ISL