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Supervise the Documentation Center (Doc Center) internal/external audits and CAPA in Costa Rica with the objective of ensuring the efficient and effective functioning of the different processes and services provided through the timely performance of tasks and complying with the guidelines of the Quality System and regulatory bodies. Provide the tools and management necessary for the development and growth of the different members of the team.
Main Responsabilites
Establish direct and coordinate departmental objectives metrics and departmental systems as well as resolve conflicts and work in coordination with other departments to ensure compliance with company objectives.
Ensure regulatory compliance with the documentation center as well as ensure the correct distribution of area resources and action plans to meet the needs of the plant
Promote and support continuous improvement initiatives related to the processes in charge or introduction of new products with the objective of identifying and coordinating required activities specific to the areas.
Manage the NCRs (CAPA) process in compliance with the deadlines and metrics established by the company.
Lead the internal audit program of the plants Quality System and ensure its execution.
Lead the preparation and execution of audits or inspections external to the plants Quality System organizing the necessary resources and documentation for an adequate reaction to such audits or inspections.
Coordinate and oversee resources for the Documentation Center process. Ensure compliance with applicable regulatory requirements
Fulfill the other functions inherent to the position and those assigned by your immediate boss. Ensure the motivation of employees in the areas by ensuring that the behaviors promoted by Abbvies culture are reinforced and recognized in a timely manner in a formal and informal manner. Define and control the budget of the areas in charge.
Ensure compliance with corporate and legal EHS requirements through compliance with internal policy and procedures. Likewise ensure compliance through the adoption of necessary strategies internal controls communication and training.
Continuously improve EHS outcomes through leadership commitment and participation in all EHSrelated initiatives.
Qualifications :
Baccalaureate in Industrial Engineering Business Administration or related career.
Leading Auditor Certification
Certification in Risk Management Green Belt CQE or CMQOE (desirable)
Proficiency in the English language (oral and written).
At least 50% progress in the Masters degree in a related career is desirable.
Experience of at least 5 years in related positions within the quality system and desirable experience in handling complaints in the medical industry.
Experience of at least 3 years in supervising personnel
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
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No
Employment Type :
Fulltime
Full-time