Join our growing QA team in a key role which provides Quality subject matter expertise (SME) and oversight to enhance our Quality Management Systems, thereby supporting global pharma in the production of life saving medicines and therapies.
Summary
Join our growing QA team in a key role which provides Quality subject matter expertise (SME) and oversight to enhance our Quality Management Systems, thereby 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 our QMS and support our Client’s processes. The position is at the Castlebar, Co.Mayo facility and will report to the Senior Quality Engineer.
Essential Duties And Responsibilities
These include the following, others may be assigned to meet business needs.
* Collaborate as a solution-oriented 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 value-added improvements and key performance indicators.
* Review and follow-up 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 Meissner 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 Meissner SOPs.
* Other duties as required to support the growing Quality organization.
Qualifications, Education & Experience
The requirements listed below are representative of the knowledge, skill, and/or ability required to successfully function in this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
* 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.
* Bachelor’s degree in science, engineering or business preferred.
* Willingness and availability to travel on company business.
Physical Demands
Occasional work may be done in an ISO Class 7 cleanroom environment. Powder free gloves, face masks, hairnets, gowns, and shoe covers must be worn. Because smokers continue to shed thousands of smoke particles even hours after smoking a cigarette and these particles will damage our products, only non-smokers are permitted to enter or work in the cleanroom. As a result, the successful candidate must be a nonsmoker.
Meissner is proud to be an Equal Opportunity Employer. #J-18808-Ljbffr