Engineering Compliance Lead
5+ years experience in similar role
- Sound understanding of a breath of engineering standards and practices.
- Competent in GMP and EHS mandatory requirements and policies
- Strong in influencing techniques.
- Effective demonstration of managing compliance and upholding standards
- in a practical environment.
- Knowledge of external institutions, authorities and benchmark organizations in engineering practice, skills development, assessment and accreditation.
- Effective demonstration of managing compliance and upholding standards in a practical environment.
- Knowledge of external institutions, authorities and benchmark organizations in engineering practice, skills development, assessment and accreditation
Job Description Summary-Job Family - Internal Quality Audit: Performs Quality Audit on internal functions
Job Family Group - Quality: Develops and implements programs to establish and maintain quality standards of existing products, and internal systems and processes. Develops policies, procedures and methods to check product, material, components and/or operational quality and improve same.
- Encourage team members to come up with multiple options / assess all aspects of suggestions and be open to "thinking outside the box"
- Taking personal responsibility for supporting and developing others by acting as a coach or mentor.
- Allocating important projects and challenging responsibilities to others for the purpose of their development.
- Establishing a series of measurable improvement processes.
- Adding value to internal and external customers through the ongoing setting and tracking of stretching performance improvement measures.
- Giving ongoing feedback to raise collective performance.
Enable & Drive Change
- Enhancing the scope for initiative by reducing barriers to the performance of self or others.
- Ensuring the implementation of longer-term plans or delivery of large-scale projects.
- Ensure all projects being worked on are aligned to End Customer (internal or external).
- Ensure team members understand alignment re tasks to customer
- Creating a climate where people feel free to speak knowing they will be heard and valued.
- Building a culture of trust and openness where colleagues, customer and stakeholders can speak out without fear of criticism.
The key responsibilities of this role will include:
- Establish an effective interface with Quality Operations and all engineering operations groups
- Is the first point of contact for all level 2/3/4 audits
- Ensure the site preventative Maintenance and Calibration Program is aligned and compliant with the GSK Quality Management System
- Act as QMS owner across all Engineering Operations
- Management of the Engineering Corrective and Preventative Action (CAPA), CARISMA, Notification of Event (NOE) and investigation processes. This will involve mapping the current in-place systems, defining the UDE's and implementing process improvements. This will involve engaging with key stakeholders from the site Quality and Manufacturing Operations.
- Management of the Engineering Self Audit process across all Engineering Operations. This will involve working with the respective Team and Operations Managers to ensure the Engineering Operation is Inspection Ready.
- Management of the Engineering Training Program, working with the respective Team and Operations Managers to ensure training compliance across all engineering operations.
- Management of the Engineering Stores function on site.
- Establish Key Performance Indicators (KPI's) for the Engineering Operation.
- Be the focal point for Engineering alerts and drive responses
- Ownership of Quality and EHS Alerts tracking / facilitating gap analysis, extracting information from SME's and writing up investigations and CAPA forms
- Accountability for the Site Action Tracker monitoring / maintenance
- Ownership of Engineering Quality Deviation process (organizing
- clinic's with SME's and writing up investigation forms and CAPA's)
- Accountability for the Engineering related PER schedule
- Near Miss administration to excel database
- Risk Assessment action administration
- Raising of Equipment Change Control for equipment upgrades / modifications
- Ownership of the GES compliance process on site ensuring all assessments and actions are tracked to completion
- Executes TP13 audits.
- Updates Engineering SOPs as required.
- Accountable for the practicality and effectiveness of information systems supporting compliance and standards.
- Accountable for upholding agreed standards of practice including GES's and TP13
- Accountable for updating and maintenance of the Engineering SOP's
- Accountable for ensuring site wide engineering standards in GMP and EHS are fully aligned with, and meet, the requirements of QMS and other GSK/GMS policies and procedures.
- Accountable for ensuring that engineering is organized to effectively, efficiently and successfully front level 2, 3 and 4 audits.
Environmental Health & Safety (EHS) Responsibilities
- Perform duties in a compliant manner and behave in accordance with Site SOP's GSK EHS Standards and guidelines and relevant legal requirements.
- Read and understand Standard Operations procedures applicable to Role.
- Report all accidents, incidents and any EHS issues using the appropriate process/ System to your manager, or if required the Occupational Health Advisor.
- Maintain work area in an inspection ready state and clean as you go to maintain good safe housekeeping standards, Be aware of the impact of your job activities on EHS issues
- Ensure all engineering changes made have safety considerations and best practices as core attributes
- Ensure Basis of safety files are available and up to date re processes
- Perform duties in a compliant manner and behave in accordance with our Quality Management System requirements.
- Participate fully in the site's quality initiatives and ensure that all relevant quality standards are adhered to.
- Maintain GMP standards where appropriate to your role
- Read and understand relevant Standard Operating Procedures and Global Quality applicable to role
- Management Policies relevant to your job role
- Attend training and complete assessments as required
- Ensure Quality and GMP is at the forefront of changes proposed.
Problem Solving & Innovation
Detailed and structured problem solving approach to be used for all process issues which should include but not limited to:
oTimeline of events
oRoot causes/potential root causes
oDetailed action plan with timelines and responsibilities.
You may apply for this position online by selecting the Apply now button.
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