Website Asset Recruitment
Based within the QA department, the QA Engineer will be responsible for providing the company with technical and quality resources to manage the quality deliverables on projects, coordinate the necessary activities for ensuring the timely closure of internal/external quality issues and ensuring an effective quality system.
Essential Duties and Responsibilities
· Quality review and approval of qualification/validation documentation and associated data for conformance to regulations, Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria.
· Work in conjunction with Engineering Departments to co-develop design verification & validation protocols for new products and for changes on existing products, review and approve protocols/studies, and perform general oversight responsibilities for the validation process (both equipment and processes).
· Ensure all equipment and processes are safe, effective and qualified in compliance with industry standards and regulatory expectations.
· Active member of the QA review board to provide overall quality direction and oversight for key functional areas (i.e. PEV, QC, Supply Chain, Engineering, CSV), ensuring that programs, policies and procedures are robust and in keeping with regulatory and client expectations
· Act as a Quality point of contact and support decision making during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet client and regulatory expectations
· Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations
· Perform all activities in compliance with client safety standards and SOPs
· Assist in implementation of global standards and procedures into the site Quality Systems.
· Provide regular reporting for KPIs, metrics, dashboards and other efforts
· Participate in other projects/duites as assigned.
· Bachelor’s degree in an Engineering or Scientific related discipline.
· Robust experience in a Quality Engineering/Quality Assurance role for Biologics, medical device or pharmaceutical manufacturing.
· Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous);
· Demonstrated knowledge of GxP regulations (e.g. EU-GMP, FDA, ISO)
· Understanding of principles of Validation and New Product Introduction and be familiar with Computerised System Validation, Method Validation, Shipping Validation, Cleaning Validation and Process Validation.
· Experience in change control, non-conformance, corrective and preventative actions, and validation practices
· Ability to operate across functional boundaries, both internal and external
· Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration
· Prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
· Critical thinking skills
· Mobility in regard to domestic & international travel is a prerequisite