Job Description

We are currently sourcing a Training & Documentation Specialist to coordinate the development and maintenance of the AbbVie training program & document control system for our Medical Device facility in compliance with all applicable company and regulatory requirements.

Based at our Ballytivnan site in Sligo, the Training & Documentation Specialist will manage the learning & document management system to ensure compliance with Quality and Regulations industry standards.

Key responsibilities:

Coordinate our document and learning management systems ensuring compliance to site cGMP and all regulatory requirements.

Identify training requirements on learning and document management systems ensuring access is controlled and measured.

Assist with external audits and inspections through the coordination, preparation, and compilation of document packages for audits.

Develop and maintain a competency-based training program for relevant employees. Work with SME’s on Instructor-led training programs to identify, support and implement continuous improvement initiatives, competency-based assessments, and e-learning solutions.

Ensure that all employees involved in manufacturing activities are adequately trained in cGMP and all other relevant Quality requirements.

Promote a culture of “on-time training” by working closely with managers, team leaders, and employees to ensure training timeliness and compliance.

Manage the train the trainer program to ensure all trainers are appropriately qualified to deliver training.

Comply with the EHS policy and procedures and demonstrate EHS best practices in all work activities

Support a culture of EHS excellence by recognizing and submitting opportunities for EHS improvement on the EHS system.

Education:

· A relevant 3rd level degree with a Master’s Degree or Post Graduate Diploma strongly preferred.

Job/Technical Skills:

· 3 years’ experience in a regulated manufacturing setting.

· Proficient with Microsoft Word with a solid understanding of the review and formatting tools is required

· Competent using Outlook, Visio, Excel, PowerPoint is required

· Expertise in proofing and editing controlled documents for spelling, grammar, formatting, and cGMP compliance is required.

· Experience with the use of electronic systems to manage, edit and control documents is preferred.

· Previous experience in a fast-paced and deadline-driven environment is required.

Equal Employment Opportunity Employer:

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate based on race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

Additional Information
Travel: No
Job Type: Experienced
Schedule: Full-time
Job Level Code: IC

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