Job Description I. Department Overview: The Quality Department is responsible for creating/maintaining the Quality Management System (QMS) for the Guaynabo facility. The Quality Management System includes Documentation Control, Investigation and Corrective Actions Management, Training, Internal/External Audits, Customer Correspondence, Validation, and also includes QA of the Operation such as process monitoring and batch record review and release. II. Essential Functions: The Quality Manager is responsible for all regulatory and quality assurance functions at the Guaynabo facility. He/She will lead a team of QA Auditors and will carry the responsibility of ensuring that the day-to-day Quality function is consistently executed. According, the Quality Manager will ensure that Quality systems are employed, improved, and harmonized across the facility and are in line with corporate guidelines to effect consistent execution. The Quality Manager will drive a culture of continuous improvement to ensure that Quality is “built into” rather than “inspected into” the Operation. Responsibilities Include: Leads the implementation of Corporate Quality Policies through the development and improvement of site-wide Quality procedures, and drives improvement of Quality Systems to ensure that customer and regulatory agency requirements are consistently met. In partnership with the Director of Operations and Production Managers, leads a continuous improvement activity to ensure an efficient and compliant process. Manages a real-time batch record review process. Leads and manages all customer related audits and regulatory inspections. Defines standard processes and systems with the objective of building Quality into the manufacturing process. Responsible for the leadership and development of the Quality Assurance team and includes talent development and overall management. Has primary responsibility for managing Quality metrics per Corporate guidelines. Presents quality metrics and improvement plans at weekly management meetings and as required. Counsels senior management on the regulatory demands which impact achievements of appropriate quality and compliance standards. Has critical decision-making authority in the handling of regulatory agency, customer representatives and batch release. Responsible for the annual budget setting for the QA organization within the scope of responsibility. Holds employees accountable for safety, Quality, throughput, and cost performance – coordinates recognition, training, discipline, termination and hiring process. Ensures that change controls/Corrective Actions /Customer Complaints are managed and responded to in a timely fashion. Ensures compliance with all OSHA and CGMP requirements. Managing a team III. Position Requirements: Reports to: Senior Quality Manager Supervises: Quality Inspectors Quality Engineer Quality Team leader Education/Experience: 4-year undergraduate BS degree Minimum of 5 years of management/supervisory experience required Knowledge/Skills Requirements: Expert level knowledge of FDA cGMP’s preferred . Basic knowledge of Lean Six Sigma preferred Experience in Pharmaceutical industry preferred Proven track record of improving quality, efficiency, and workflow in a production environment Personal/Professional development history Strong communication skills – written and verbal with bilingual skills (English & Spanish) Customer interaction Good computer skills, knowledge of MS office Unique Requirements: Leadership skills : Lead by example; take charge; good judgment; decisiveness; provide direction; coach/develop Analytical skills : Situation Appraisal; Problem Analysis; Decision Analysis; Potential Problem/Opportunity Analysis; Statistical Analysis Change Management : Overcome barriers/obstacles; flexiblility /adaptability Quality Awareness : Quality System ISO ; Statistical Process Control; Continuous Improvement; cGMPs Health, Safety, Environment : Regulatory Compliance Manufacturing : Process Improvement; Material flow and Process Flow; Performance Measurement; Lean Manufacturing Concepts Operations : Component Requirements; Planning; Scheduling Pharmaceutical Packaging Safety : OSHA Financial Management : Business Plan; Facility Financials Diversity : Multi-cultural work environment IV. Work Environment: The performance of this position may occasionally require exposure to the manufacturing areas where the use of personal protective equipment such as hearing protection may be required. Primary environment: ambient room temperatures, lighting and traditional office equipment as found in a typical office environment. Company Description Essentra PLC is a diversified manufacturing company with an impressive history of success that spans over 50 years. Products include a vast array of products, packaging and components that are used in many different industries including healthcare, food and beverage, electronics, and energy. Publicly traded on the London Stock Exchange with over £1 billion in revenue, the organization has grown significantly over the past few years by complimenting steady organic growth with strategic acquisitions that have expanded the product portfolio and strengthened their global presence. With operations in 33 countries around the world, the company is organized into three Strategic Business Units (SBUs): Component Solutions, Health and Personal Care Packaging, and Filtration Products. The Americas Region, which includes approximately 22 manufacturing and distribution locations and 2,200 employees across the US, Canada, and Latin America, accounts for over one third of global sales. The dynamic culture is entrepreneurial, fast paced and results driven. The Company’s Key Principles are centered around building a winning engaging team with the freedom to operate in an open, honest and safe environment.
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