Quality Management Systems Specialist
Quality Management Systems Specialist
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Job Description
ID Recruitment are working with a growing manufacturing company in Castlebar Mayo to recruit a Quality Management Systems Specialist.
This role will join the Quality Assurance team in playing a key role in providing Quality subject matter expertise (SME) and oversight to enhance the Quality Management Systems supporting global pharma in the production of life saving medicines and therapies. You will be responsible for ensuring that the QMS processes are efficiently maintained and conform to internal and external client requirements engaging cross functionally with exceptional SME team members to enhance the companies QMS and support Client s processes.
Essential Duties and Responsibilities include;
- Collaborate as a solutionoriented team member to work alongside the commercial and technical operations teams delivering QA objectives to support business growth
- Track and report metrics and key performance indicators for the Quality Management System
- Collaborate with stakeholders to identify and support valueadded improvements and key performance indicators
- Review and followup on open actions related to Corrective and Preventative Actions (CAPA) Out of Specification (OOS) reports and Deviations
- Support / host Client quality audits inclusive of addressing findings and required actions
- Management of the Internal Audit program including coordinating audit schedules reviewing findings tracking corrective actions and providing insights and initiatives to drive continuous improvement
- Provide forward thinking innovative solutions and identify opportunities to add value to the teams deliverables
- Assist in the development of appropriate systems and processes to ensure delivery of information across functions to support enhanced performance culture
- Document Control Site lead for managing the company s SOPs and Document Control
- Manage quality training programs at Castlebar site to ensure these effectively mirror what is in place at HQ
- Site lead for training compliance to SOPs.
- Other duties as required to support the growing Quality organization
- Minimum 3 years of professional experience in the pharmaceutical industry in Quality Assurance focused role
- Team Oriented: Ability to integrate with the organizational Core Values culture and team climate
- Detail Oriented: Ability to focus on the details yet understand the overall direction
- SelfMotivated: Identifying what needs to be done and doing it before being asked or before the situation requires it
- Results Driven: The ability to focus on the desired result of one s own or one s unit s work setting challenging goals focusing effort on the goals and meeting or exceeding them
- Adept at multitasking and working in a fastpaced environment
- Strong clear and concise communicator both internally and externally with pharmaceutical clients
- Bachelor s degree in science engineering or business preferred
- Willingness and availability to travel on company business
Physical Demands
This role will require occasional work may be done in an ISO Class 7 cleanroom environment. Please be aware that when entering this environment you will be required to wear powder free gloves face masks hairnets gowns and shoe covers.
Minimum 3 years of professional experience in the pharmaceutical industry in Quality Assurance focused role Team Oriented: Ability to integrate with the organizational Core Values, culture, and team climate Detail Oriented: Ability to focus on the details yet understand the overall direction Self-Motivated: Identifying what needs to be done and doing it before being asked or before the situation requires it Results Driven: The ability to focus on the desired result of one s own or one s unit s work, setting challenging goals, focusing effort on the goals, and meeting or exceeding them Adept at multi-tasking and working in a fast-paced environment Strong, clear and concise communicator both internally and externally with pharmaceutical clients Willingness and availability to travel on company business
Education
Bachelor s degree in science, engineering or business preferred
Employment Type
Full Time
