What are the responsibilities and job description for the Calibration SME position at GSK?
Posted Date: Jan 9 2020
The primary purpose of the Calibration Subject Matter Expert (SME) is to ensure the effective and compliant delivery of the calibration program at R&D WREF (Worldwide Real Estate and Facilities) facilities.
The role will ensure all site equipment requiring routine calibration and calibration facilities are maintained to the required standards and compliant with all current regulations. It will also provide technical support to site leadership to drive performance, effectiveness and compliance improvements, as well as implementing systems and best practices to drive continuous improvement.
The role will work closely with service partners to ensure the calibration schedule is adhered to, all defects, deviations and audit observations are managed, data integrity is maintained, and they provide an effective calibration service on site.
Working closely with the operations teams to maintain and optimize the technical performance in terms of reliability, safety, and environmental integrity of our sites.
The Calibration SME also reviews and approves calibration plans, both internal and external, ensuring that all calibration service contracts are integrated properly.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
- Ensure new instruments are appropriately calibrated and introduced to the site’s calibration program.
- Ensure effective vendor assessment of Service Partners and Third Parties.
- Provide technical support to site and service partner operations, compliance and quality groups.
- Ensure effective service partner performance: Service Level Metrics, Management Monitoring.
- Ensure equipment records and documentation related to tests, inspections, modifications and repairs adhere to ALCOA+ principles.
- Ensure Service Partners plan and schedule calibration activities to minimize site impact and achieve adherence to required schedule.
- Ensure calibration deviations are appropriately assessed and managed.
- Demonstrate understanding of appropriate GSK standards, regulations and procedures relating to the calibration process.
- Create and lead improvement procedures generated by various sources: CAPA, RMS, IBM.
- Provide technical support for capital improvement projects and site inspections.
- Support engineering groups to resolve reoccurring issues, deviations and incidents.
Why you?
Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:
- 3 years’ experience in calibration or instrument support services in a GMP regulated plant environment.
- Familiarity with the use of a Computerized Maintenance Management System (CMMS) for work order planning/scheduling, spare parts/inventory management and asset master data tracking.
- Expertise in risk assessment methodology, incident investigation, and root cause analysis.
Familiarity with continuous improvement methodologies.
Broad technical knowledge of manufacturing plant operational maintenance.
Practical experience in troubleshooting with development of engineering solutions.
Knowledgeable of cGMP’s principles.
Excellent in Microsoft Project, Word and Excel.
Preferred Qualifications:
If you have the following characteristics, it would be a plus:
- 5 years’ experience in instrumentation supervisory roles, preferably in the pharmaceutical, consumer health care or food industry.
- Excellent oral and written communication skills.
- Must be able to work in a complex environment taking a balanced view across all interested parties and across business lines.
- Excellent communication skills and ability to influence effectively at all levels within the organization.
Why GSK?
Our values and expectations are at the heart of everything we do and form an important part of our culture.
These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities:
- Agile and distributed decision-making – using evidence and applying judgement to balance pace, rigour and risk .
- Managing individual and team performance.
- Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution.
- Implementing change initiatives and leading change.
- Sustaining energy and well-being, building resilience in teams.
- Continuously looking for opportunities to learn, build skills and share learning both internally and externally.
- Developing people and building a talent pipeline.
- Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation.
- Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally.
- Budgeting and forecasting, commercial and financial acumen.
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