Automation Compliance Engineer

Quanta Consultancy Services Ltd
40 - 50 per hour
04 Nov 2017
16 Nov 2017
Contract Type
Full Time
Job Title: Automation / Engineering Compliance Specialist Department: Tech Ops Location: Ireland Rate dependant on experience Summary: requirement for a Compliance Specialist for the startup, commissioning and sustaining of a pharmaceutical manufacturing facility in Ireland. Essential Duties and Responsibilities include, but are not limited to the following: - Responsibility for ensuring compliance with all aspects of Quality for the facility in Automation/Engineering. - Manage Deviations, CAPA, Change Control, Audits, and Quality risk management. - Participates in internal, regulatory and customer audits. - Reviewing and maintain procedures, polices and other instructional documents with a focus on continuous improvement. - Maintaining electronic systems used for change control and deviation management. - Responsible for the approval of deviation notification, driving deviation investigation and tracking implementation through to closure of associated corrective action. - Responsible for generating and tracking Quality compliance metrics. - Coordinate Compliance activities with and seek team support from QA, Validation and Manufacturing. - Responsible for generating and maintaining Life cycle document across automation platforms. - Ensure consistency by provide guidance and direction in the preparation of all Compliance/Validation documents. - Liaise with QA to provide accurate and efficient communication ensuring clarity on all technical investigation and proposed technical solutions. - Maintains knowledge of current good manufacturing practices (cGMPs). - Provides periodic reviews of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, preventative maintenance records/work orders, etc. Education and Experience: - Primary degree in Science/Engineering discipline. - You will have a minimum of 5 years` experience working with validated Automation systems in the pharmaceutical manufacturing environment. - Direct experience and in depth knowledge of automation platform desirable. - Ability to work on own initiative, without direct supervision from management. - Team player with an ability to work well across various departments on site as well as business partners. - Excellent written, presentation, communication and investigation skills. - Deadline focused individual.
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