Job Summary:
This role is part of an 18-month Rotation Graduate Program within the Quality Department.
Graduates will have the opportunity to undertake three 6-month rotations across different areas in Quality such as Compliance, Quality Assurance, Quality Operations, Validation, Microbiology and Supplier Quality.
The Rotation Graduate Program is designed to provide the Quality Graduate a diverse range of experience to complement their studies.
Daily activities, leading and working in projects that will allow them to develop their skills within a cross-functional team.
Essential Duties and Responsibilities:
* Provide quality support and oversight to Engineering and Operations activities.
* Draft and approve quality documentation to meet West, Customer and Regulatory requirements.
* Support and lead investigations into material / product issues to ensure a thorough root cause, containment / corrective and preventive actions are implemented.
* Ensure timely and effective closure of daily quality issues, providing support to quality and shift personnel when required.
* Review batch paperwork for release of product for shipment.
* Manage quality-related aspects of materials used across the business and their suppliers.
* Execute incoming inspections, non-conformance investigations, monitoring and communication activities with suppliers.
* Maintain the ongoing compliance of the Quality Management System, including the coordination of document change activities.
* Track and trend quality data to support metric reporting and quality improvements across the business.
* Support internal and external audit programs.
* Support NPI projects and ongoing process revalidation focusing on customer specification, Process Risk Management, Validation Master Plan, and protocol reviews.
* Assist in managing the onsite laboratory and the validation and monitoring of the microbiological / particle testing processes required to support plant operations and regulatory / customer requirements.
* Manage quality projects in support of continuous improvement e.g., Lean Projects.
* Coach and drive a culture of compliance and continuous improvement.
* Act in accordance with the company's Guiding Principles and adherence to the corporate Code of Conduct.
* Compliance to all site Environmental, Health and Safety requirements, training and regulations.
* Compliance to all local site company policies, procedures and corporate policies.
* Perform additional duties at the request of the direct supervisor.
Basic Qualifications:
* Must have recently graduated with a bachelor's or master's degree in Engineering/Quality/Science.
* Must have excellent communication skills both oral and written.
* Must possess computer literacy.
* Must possess good communication/interpersonal skills.
* Must be detail oriented, organized, flexible and be able to handle multiple tasks and time critical projects/deadlines.
Preferred Knowledge, Skills and Abilities:
* Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
* Knowledge of Lean / 6 Sigma tools and Project Management tools is an advantage.
* Knowledge of and / or experience in ISO 13485, 21 CFR Part 820 and EU GMP is an advantage.
* Able to comply with the company's safety policy at all times.
* Able to always comply with the company's quality policy.
Travel Requirements:
* Must be able to travel up to 5% of the time.
Physical and Mental Requirements:
* Physical Requirements: must be able to exerting up to 10lbs / 4kg of force occasionally, and / or negligible amount of force frequently or constantly to life, carry, push, pull or otherwise move objects.
* Mental Requirements: must be able to communicate with other members of the team and other departments, be quick decision maker, have knowledge to interpret data.
Delegation of Duties:
When absent from the site duties and responsibilities will be delegated to the following designates:
* Senior Quality Specialist
* Respective Rotation Manager