Engineering Compliance Specialist
An Engineering Compliance Specialist is required to join a leading biotechnology manufacturing company based in Limerick. This position offers an impressive and unique opportunity for interested candidates. This position requires people who want to be challenged, have a passion for success, and a constant drive to exceed expectations.
This role will be responsible for responsible for ensuring cGMP compliance for the Tech Ops Engineering & Automation Department. This is a perfect opportunity to join a select team that has already established itself as a frontrunner leading the way in the Pharmaceutical/Biotech industry.
Key Responsibilities
- Facilitates reviews and revisions of Department related SOP's, life cycle documents, plans and policies for each group within the Department.
- Acts as a liaison between Engineering & Automation and onsite quality and regulatory groups to define and address compliance related items.
- Identifies opportunities for continuous improvement of compliance and leads improvement initiatives.
- Provides support, information, and assistance to individuals, groups and management with the initiation, review, submission, and follow-up of documents such as Change Controls, EOE's, NOE's, DNF's, risk assessments, impact statements and corrective/prevention action plans.
- Participates in investigations and root cause analysis for any issues of non-compliance.
- Provides periodic reviews of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, preventative maintenance records/work orders, etc. to assess for compliance with established quality standards, policies and procedures.
- Provides tracking and trending for maintenance of related compliance activities i.e. quality instances and PERs.
- Participates in and obtains results of department quality and regulatory audits.
- Specifies and coordinates training, OJT and SOP, for Automation, Engineering and contracted personnel.
- Maintains knowledge of current good manufacturing practices (cGMPs).
Education/Experience
- Requires BA/BS (engineering or scientific related field preferred) and 3+ years of related experience working in a cGMP environment or in the operation of an industrial facility. May substitute relevant experience in lieu of education.
- 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.
Interested? Contact Jack on 01-6455250, or Click Apply below!
