Calibration Supervisor WD 210699
Are you looking for an operations leadership role that enhances your technical expertise in a state-of-the-art manufacturing environment? If so, this Calibration Supervisor role could be an exciting opportunity to explore.
As a Calibration Supervisor, you will supervise Facility Calibration and Measures (C&M) operations for cGxP manufacturing facility to include:
· Management of the site calibration schedule
· Supervise calibrations and measurements operations for cGMP manufacturing facility, manage calibration SOPs.
· Process vendor calibration related documents, vendor calibration deviation investigations.
· Maintains and performs corrective, preventative maintenance calibrations on GMP & non-GMP equipment
· Supports other departments to troubleshoot, test, repair and optimize instruments, equipment and control systems.
· Work across boundaries and engage others positively and constructively.
· Proficiency in technical writing, CAPA management and deviation management.
· Support overall site calibration processes to include resource leveling, conflict resolution, scheduling and proactive planning.
· Able to follow all maintenance safety practices including Lock Out/Tag Out procedures and Risk Analysis prior to starting the maintenance tasks and adhere to GSK safety programs.
· Conduct Departmental L-1 Safety and L-1 Quality Audits
· Conducting instrument out of tolerance investigations
· Oversight and administration of calibration related training
· Implementation of process improvement initiatives within a defined area.
· Complete required documentation to certify the verification and calibration per cGMP (current good manufacturing practices) requirements.
· Perform data entry into calibration SAP database
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Environment Health & Safety:
· Responsible for the application of GSK safety and environmental guidelines in facilities and calibration groups.
· Promotes a safety culture, perform work in a manner that ensures the safety of co-workers, equipment and self.
Quality & Compliance:
· Ensures all activities are executed following quality and regulatory standards.
· Promotes quality mindset and quality excellence approach to all activities.
· Complies with LSOP and departmental documentation requirements.
· Attends all mandatory training and ensure training compliance of calibration staff.
· Adhere to all GSK Quality Management System (QMS) policies and procedures as applicable for functional area.
· Drive continuous improvement and operational excellence through the application of LEAN and Six Sigma methodologies
· Ability to manage multiple projects and tasks in order to achieve deliverables and adhere to timelines and budgets.
· Ensures efficient coordination of projects and tasks as assigned by management.
· Proactively keep management informed of progress and activities.
· Actively promote change, demonstrating the ability to maintain high personal performance levels as the organization evolves.
We are looking for professionals with these required skills to achieve our goals:
· Bachelor's Degree; Preferably in Science, Engineering, or Mathematics.
· Extensive experience working in a cGMP Pharmaceutical environment and extensive operations, facilities maintenance or calibration experience (7+ years)
· Experience managing Automation technicians, Calibration Technicians and Automation Engineers
If you have the following characteristics, it would be a plus:
· Supervisory experience with direct reports (7+ years) preferred
· Prior experience as a technical authority / subject matter expert on usage decisions, design reviews, risk assessment, component level impact assessments required.
· Regulatory audit experience (FDA/EMA site inspections), with demonstrated active participation in the inspection process as a respondent to operations/maintenance/calibration inquiries required.
· Pharmaceutical / medical device facility experience required
· Able to work in a dynamic, cross functional calibration team supporting other functions which may include Engineering, Validation, Manufacturing, Facilities, Quality and consultants.
· Able to work independently under little to no supervision in a team environment.
· Advanced computer skills utilizing MS Office suite applications and Building Management Systems.
· Advanced written and verbal communication skills.
· Proven project management, industry process knowledge, skills management, communication, time management and troubleshooting skills.
· Requires independent decision making and prior experience working with SAP calibration software.
· Adept at working both as an individual and in varying groups in a dynamic, multi-tasking environment