- 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.
- 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: firstname.lastname@example.org