Role Title:
Quality Assurance Specialist
Role Type:
Permanent
Location:
Co. Westmeath
The Quality Assurance Specialist will be responsible for oversee the development and implementation of the Quality Management System (QMS), documentation management and updates, training program management and supporting the site with inspection readiness initiatives to ensure compliance with business objectives, HPRA standards, and all relevant regulatory requirements.
RESPONSIBILITIES
* Oversee the development, implementation, and continuous improvement of the Quality Management System (QMS) and supporting processes, including but not limited to controlled document management, event tracking, deviations, change control, CAPA, employee training, validation, calibration, supplier qualification, and regulatory compliance.
* Works closely with SMEs to assist in authoring and reviewing Policies, SOP's, WI's and Training Materials related to Quality Systems.
* Ensure accurate and complete documentation in compliance with Good Documentation Practices (GDP).
* Review and approve validation protocols, summary reports, and technical documents.
* Serve as the primary QA contact for day-to-day quality activities, ensuring adherence and compliance to procedures.
* Helps to promote a culture of quality, compliance, and accountability mindset, including continuous improvement through the establishment of KPI metrics.
* Support for internal and external audits activities.
* Support activities of Environmental Health and Safety to ensure safe and efficient operations in accordance with established procedures and compliance with regulatory agencies
* Support secondary packaging and labeling quality activities and other specific client requirements.
* Support site inspection readiness program.
* Collaborate with operations and warehouse team to establish required processes and procedures.
QUALIFICATIONS AND EXPERIENCE
* Bachelor's Degree in in science or other related discipline required, however, in lieu of a degree, 3-5 years of relevant experience of working in Quality Systems and/or Quality Assurance activities may suffice.
* Experience of GMP document review, change control, non-conformances, CAPAs, complaints, and Quality Management System maintenance.
* Experience with Inspection readiness support and conducting internal audits and regulatory inspections
* Performing root cause analysis, risk management, and CAPA investigations.
* Ability to work under pressure and meet deadlines.
* Basic knowledge of six sigma and quality tools.
* Demonstrated knowledge of industry regulations and best practice standards including but not limited to the following:
* EU Annex 11
* EudraLex Volume 4
* HPRA Guidelines
* 21 CFR Part 820
* 21 CFR Part 11
* ICH Q7-Q10
* ISO 13485
* ISO 14971
* ISO 9001
COMPETENCIES/SKILLS
* Read, write, review and interpret documents such as standard operating procedures, manuals, batch records, work instructions, specifications, protocols, quality agreements and contracts.
* Communicate clearly in writing and orally.
* Excellent analytical, prioritization, multi-tasking, communication, strong leadership skills, and the ability to work independently with limited supervision.
* Ability to support internal and external audits (e.g., FDA, Notified Body, Customer Inspections) from a documentation perspective
* Demonstrated effective collaboration and teamwork.
* Demonstrated experience working in a cGxP environment.
* Proficiency with project management tools and technologies such as Microsoft Project.
* Successfully completes regulatory and job training requirements.
* Computer skills:
* Enter data into computer using software applications for data entry, data analysis, statistical analysis, and word processing.
* Work and be proficient with e-mail systems.
* Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
* Provide support within the Quality department and cross-functionally, as directed by Quality Management.
* Time management skills
* Handle problems quickly and efficiently
* Excellent knowledge of basic computer tools (e.g. Office suite, Internet, email)
* Ability to communicate with department managers
* Excellent motivator
*This role may require periodic travel to support regulatory inspections, supplier audits, and other project activities.