Compilance Specialist is required for an innovative and rapidly growing Biopharmaceutical company in Limerick. The new facility is close to completion and is responsible for the production, packaging, labelling and delivery of biopharmaceutical medicines for global markets. The company currently markets medicines for various diseases and has a rich pipeline of products.
The team on site strive to create a culture of trust, teamwork, transparency, respect and a drive to continuously improve. This organization has an exceptional reputation based on commitment to their employees, culture and patients and have won several #1 employer awards.
If you want to succeed on a new and growing site, with innovative medicines and in an atmosphere which is intense, face paced and exciting then this is the opportunity for you .
Excellent opportunity for a Compliance Specialist with responsibility for ensuring:
o Responsibility for ensuring compliance with all aspects of Quality for Raheen Automation/Engineering.
o Manage Deviations, CAPA, Change Control, Audits, and Quality risk management.
o Participates in internal, regulatory and customer audits.
o Reviewing and maintain procedures, polices and other instructional documents with a focus on continuous improvement.
o Maintaining electronic systems used for change control and deviation management.
o Responsible for the approval of deviation notification, driving deviation investigation and tracking implementation through to closure of associated corrective action.
o Responsible for generating and tracking Quality compliance metrics.
o Coordinate Compliance activities with and seek team support from QA, Validation and Manufacturing.
The Compliance Specialist requires:
o Primary degree in Science/Engineering discipline.
o You will have a minimum of 5 years’ experience working with validated Automation systems in the pharmaceutical manufacturing environment.
o Direct experience and in depth knowledge of automation platform desirable.
o Ability to work on own initiative, without direct supervision from management.
o Team player with an ability to work well across various departments on site as well as business partners.
Call Kathy in LSC on 021 4777 329 to discuss this new Compliance Specialist role in more detail or apply directly via this advert.