Automation/Engineering Compilance Specialist 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.
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 .
As Automation/Engineering Compilance Specialist you will.
o Ensure compliance with all aspects of Quality for the Automation/Engineering group
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 will have
o Primary degree in Science/Engineering discipline – preferable.
o You will have a minimum of 3 years’ experience in a Technical role preferably in a pharma/biopharma or medical device manufacturing environment.
o Demonstrated technical writing skills in generation of documents
o Ability to coordinate with other departments or outside contractors/vendors to complete compliance tasks.
o Ability to Lead Document and generate revisions as required.
o Flexibility and willingness to take on different job tasks.
o Self-motivated / proactive approach
o Good planning and organisation skills essential.
o Commitment to meet deadlines.
Call Kathy in LSC on 021 4777 329 to discuss this Compliance Specialist role in more detail or apply directly via this advert.