Projects and Assets Officer
- Contract
Company Description
SGS is the world’s leading inspection, verification, testing and certification company and is recognised as the global benchmark for quality and integrity. With over 98,500 employees operating from more than 2,500 locations worldwide, SGS delivers trusted solutions across a wide range of industries, including pharmaceuticals and life sciences.
In Ireland, SGS provides analytical and technical services to the pharmaceutical sector through multiple laboratory locations. In 2021, SGS acquired International Services Laboratory (ISL) in Ringaskiddy, Cork, further strengthening its capabilities in pharmaceutical testing, including method development and transfer, release and stability testing, stability programme management, and scientific insourcing services.
At SGS, our work supports the safety and quality of medicines supplied to patients globally. We are committed to maintaining high technical and regulatory standards while supporting the professional development and wellbeing of our people.
We are looking for a experienced Projects and Asset Officer to Manage major projects within ISL including equipment replacement, equipment changes and software upgrades, with some guidance from senior manager. Develop plans and oversee execution. Adapt plans and priorities to address resource and operational challenges. Provide technical input to complex equipment issues. Work independently, but reliant on others to complete role successfully.
Job Description
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’s 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
Qualifications
- Science Graduate in Chemistry, Pharmacy, or equivalent education
- Good knowledge of current Good Manufacturing Practices and good knowledge of Analytical technologies
- 4 to 6 years’ experience in analytical testing
Additional Information
Core Competencies
- Strategic Thinking
- Translates Strategy into Actions
- Influences Internally & Externally
- Develop Self & Others
- Collaborates Effectively
- Builds High Performance Teams
- Embraces Change
- Leads in Uncertainty
- Delivers Superior Results
- Fosters Innovation
Expected Behaviors
- Integrity, consistency and flexibility
- Professionalism; with the client, contractors and colleagues at all times
- Compliance with SGS policies and procedures
- Participate in team meetings / Team player
- Strong analytical ability and associated problem solving
- Results and performance driven
- Excellent communication skills, both verbal & written
- Good time management & attention to detail