Compliance 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 .
The Compliance Specialist will be responsible for:
o Lead investigations and root cause analysis for all Facilities Department issues of non-compliance.
o Acts as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance.
o Facilitates all reviews and revisions of all Facilities Department related SOP’s, plans and policies for each group within the Department.
o Provides support, information, and assistance to individual groups and supervisors with the initiation, review, submission, and follow-up of documents such as Change Controls, NOE’s and DNF’s, impact statements and corrective action plans.
o Provides tracking and trending for all facilities and maintenance related compliance activities i.e NOEs, EOEs, CAPAs and Change Controls.
The Compliance Specialist requires:
o BS/BA in engineering or scientific related field with 3+ years of related professional experience in a cGMP environment or in the operation of an industrial facility.
o Minimum of 2+ years experience working in a Compliance function in a cGMP environment.
o Excellent communication skills with the ability to engage with a diverse range of individuals across all levels of the organization.
o Strong Technical writing ability.
o Proficient in MS Office (Word, Excel, Outlook, Access and PowerPoint).
Call Mairead in LSC on 021 4777 329 to discuss this new Compliance Specialist role in more detail or apply directly via this advert.