Job Information
Lilly del Caribe, Inc. Engineer-Quality Assurance Engineering in Carolina, Puerto Rico
Facilitate and drive compliance with Good Manufacturing Practices and corporate quality policies in the PR01 plant, as applied to the areas of utilities, equipment, computerized systems and facilities in oral solids manufacturing plant.Responsibilities:Ensure compliance with Good Manufacturing Practices (GMPs) and corporate quality policies with special attention to the following elements:•Participate in the definition of strategies, reviews and approvals of the qualification and validation protocols of facilities, utilities, computerized systems, if applicable, and equipment.•Evaluate and approve the impact of proposed changes.•Evaluate the impact of deviations regarding validated processes and applicable regulations to ensure product attributes are not affected. Ensure the effectiveness of the associated CAPA.•Ensure the proper identification of any trend and the generation and implementation of the corresponding action plans.•Ensure that adequate procedures are available to cover all activities related to GMPs and regulations applicable to facilities, utilities and equipment.•Manage the Self-Inspection (SI) Program for your areas of responsibility (i.e., regulatory plans, etc.). Ensure that action plans are generated and implemented for any identified deficiencies. •Ensure that Quality Systems are kept up to date by promoting a regulatory environment through specialized forums that assist in the investigation and closure of regulatory documents.•Monitor compliance with the pest control program, ensure compliance with the requirements of construction activities and routine monitoring of facilities.•Actively participate in the evaluation and approval of validations, qualifications, deviations and change proposals related to the utilities systems, equipment systems and facilities used in manufacturing processes. Evaluate and approve preventive maintenance procedures (job plans), work orders, as required, and corrective maintenance.•Ensure compliance with Data Integrity requirements under 21 CFR Part 11. Ensure compliance with computerized system validation policies and guidelines for applications used in GMP activities and automation technology.Basic Requirements:•Bachelor's degree in engineering (Mechanical, Chemical preferred)•Minimum 2 years of experience in pharmaceutical GMP environment•Experience in facilities, utilities and equipment, statistical sampling systems, quality systems, FDA regulations•Professional License of Engineer (PE) or Engineer in Training (EIT), preferredAdditional Skills/Preferences:•Bilingual (English and Spanish)•Ability to establish positive interpersonal relationships and interact with people•Ability to multi-task and work on multiple projects at once•Exercising good judgment and decision-making•Work under minimal supervision•Knowledgeable in GMPs, GDPs, Safety (OSHA), Computerized System•Strong technical writing abilities and compliance mindset.