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Quality and Compliance Manager
hace 18 horas
JLL supports the Whole You, personally and professionally.
**How we support the Whole You**:
Our benefits are a good reason to come to JLL.
We are committed to hiring the best, most talented people in our industry, and then empowering them with the resources and support to enhance their health, financial and personal well-being. Our underlying benefits philosophy is this: be fair to our people and provide opportunities for those who take advantage of our programs and resources to increase their personal and financial security.
**Benefits to eligible employees, include**:
Life, health, and dental insurance for you.
Annual Performance Bonus.
Online platform with certified courses for professional development.
What this job involves
We are currently seeking a dynamic individual for the role of Quality and Compliance Manager
**to join our team**:
**Location**: Escazu
**Work schedule**: Monday to Friday, 8:00 am to 5:00 pm.
**Work model**: Hybrid
**Contract Type**: Indefinite-term
The Quality/Compliance Manager must have a strong background in quality requirements for a Pharmaceutical Manufacturing facility from an operations, facilities, and maintenance perspective. This position is responsible for ensuring that the work conducted by the Facilities team, and its subcontractors perform the work in full accordance with contractual, procedural, and regulatory requirements within a cGMP culture environment. This Manager must have a solid understanding of cGMPs as they relate to the performance of maintenance and repairs of equipment, facilities and utilities. An Engineering background, or equivalent experience in lieu of, would be desired. He/She should be able to prepare and manage documents, investigations, CAPAs, audits, change control documentation, and training materials for use by the facilities team in the performance of their work.
In addition, this position is expected to interface with the site’s quality unit to ensure that through the established Quality Agreement all applicable regulations and procedures are followed, and that the work performed by the team is documented and recorded in the proper fashion. He/She is responsible for sustaining a Quality program for a state of the art cGMP manufacturing facility. This person must have experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity. A background and understanding of FDA regulations including 210 CFR part 210 and 211 would be desired but not required.
The Quality/Compliance Manager must have a strong commitment to quality assurance, and a willingness to help develop a quality first culture on the Site. Must be self-motivated, detail oriented, comfortable working in a dynamic team environment with mínimal supervision. He/She must have good oral and written communication skills including the ability communicate to all levels of management and interface with a diverse customer base including technical and non-technical personnel.
What is your day to day?
Perform investigations of significant event deviations along with the corresponding root cause analysis (RCA), impact assessment and trend evaluations.
Lead assigned Corrective and Preventive Actions (CAPA)
Developments and reviews of trend analysis reports related to the facility scope of work.
Management of the GxP Contractors compliance program (e.g. qualification, agreements, audits, performances, etc.).
Oversee the quality/compliance program of building support systems including maintenance of equipment, environmental monitoring systems, HVAC, utilities, and site support services such as calibration, janitorial cleaning, pest control, garments, and shipping/receiving activities.
Manage the site’s self-assessment program along with the corrective actions as a result of.
Maintain all infrastructure and compliance documentation for the facility for the purpose of maintaining regulatory compliance with Contractual, Procedural, Federal, State or Local law requirements.
Reads and understands the applicable Service Level Agreements, helps achieve the Key Performance Indicators and scores favourably on the client satisfaction surveys.
Support and oversee the team’s training compliance program along with the review of corresponding training curricula
Ensures appropriate follow up with customers
Seeks to continuously improve quality processes, systems and overall client satisfaction
Provides direction/information to vendors, facilities staff and service providers as required to ensure that quality assurance expectations are communicated and followed.
Performs additional job duties as requests, analysis, and reporting
Desired experience and technical skills
BS degree in Science is desired with a minimum of 4 years of experience in quality engineering, facilities design, and production/facility operations or equivalent.
Knowledge of Quality Engineering techniques such as Investigations, RCAs, CAPAs, Audit programs, Vendor Qualificati
