Job Descriptions

Your Key Activities will include, but are not limited to:

• Complete Batch File Reviews in line with GMP standards for area of responsibility.
• Manage the file review system ensuring product shipments are consistently met and customer requirements are adhered to.
• Assist in the preparation for site MOH and customer inspections as required
• Attend all routine meetings as required and support site initiatives by fostering an environment of continuous improvement, for example: EHS initiatives; safe start card, interventions, ANDON Boards/APEX meetings, Golden Quality rules.
• Provide quality input as required, providing information on day-to-day activities as a member of the site quality team.
• Work with business unit representative and supporting functions to ensure site and global quality metrics are achieved and exceeded each month through the implementation of department process improvements and working with key site vendors to ensure high quality standards are implemented.
• Work with the Quality manager on the delivery of the company quality plan and global regulatory requirements for the site
• Assess quality implications of new regulatory guidance and implement necessary changes
• Comply with quality requirements for process changes & new product introductions as deemed necessary
• Ensure effective recording, analysis, and reporting of quality KPIs ensuring issues impacting quality performance are addressed and drive continuous improvement.
• Demonstrate active support and involvement in successful progress of compliance initiatives to enhance the site quality program.
• Represent the company in Ministries of Health inspections as required
• Maintain strong relationships with management and colleagues in the business units, support functions and the quality site and global functions.  Articulate the necessary quality requirements in a clear, concise, and persuasive manner
  
  

Education and Experience

• Leaving Certificate required as a minimum
• Relevant Third Level Qualification is desirable
• While hands-on experience in manufacturing is not essential you must demonstrate a clear understanding of working within a regulated environment.
• Establish excellent working relationships with all functions within the business unit and QA team. Team player who can collaborate with others to achieve targets and goals.
• Excellent communication and presentations skills, both written and oral while articulating the quality requirements in a clear, concise and persuasive manner.
• Excellent analytical skills. Ability to plan and schedule.
• Identify and understand issues, problems and opportunities whilst providing a viable solution.
• Ability to work in a fast, dynamic, environment whilst being able to adjust readily to meet unexpected constraints.
• Drive, high energy, maturity, and ability to work under pressure and deliver results; get things done (an action-oriented approach); overcome obstacles.
• Receptive to the ideas of others and welcome and accept constructive feedback, display humility where appropriate.

Skills

• Communication Skills
• Analytical Skills

Experience

• 1 year