Assoc Mgr Automation & Engineering Compliance | Collins McNicholas

Assoc Mgr Automation & Engineering Compliance

  • Reference: GJ43843
  • Job Type: Permanent
  • Location: Limerick
  • Category: Science, Pharmaceutical & Food

The position provides oversight for all aspects of cGMP compliance for Engineering & Automation Department.

Responsibilities:

  • Ensuring compliance with all aspects of Quality for the Engineering & Automation Department.
  • 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 Engineering 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.

Skills, Experience and Qualifications:

  • BS/BA in engineering or scientific related field with 6+ years of related professional experience in a cGMP environment or in the operation of an industrial facility. May substitute relevant experience in lieu of educational requirement.
  • 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.

For a confidential discussion and more information on the role/company please email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

Contact Consultant

  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
  • Connect with Amy

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