Manufacturing Compliance Specialist

Pe Global

Cork

The Manufacturing Compliance Specialist will co-ordinate and organise product change-over activities, and support the general GMP needs of the manufacturing floor staff by being an available GMP resource during shift changes and staff meetings. This position involves interaction with cross-functional departments and a close relationship with Quality. Key factors in the function of this position are flexibility, good organization, having excellent time management, solid tracking and follow up, and being self-motivated to make continual progress with minimal supervision and no need for reminders. Role responsibilities: Support the internal Compliance Programme within the manufacturing department. Self-Inspection Programme. Management of GMP Records. Tracking and Reporting Systems. Escalation process. Full understanding of basic cGMP expectations; set a good example in observance of cGMP policies. Interact with the Manufacturing floor staff regularly to answer questions related to GMPs and help champion a compliant work environment with a Continuous Improvement Focus. Lead and Participate in Self-inspections and Compliance walk-throughs of manufacturing. Report on the timeliness of compliance to set timelines on Deviations, Quality Events, Material Incidents, CAPAs, and Effectiveness Checks in Trackwise. Managing Change Requests (CRs. Work with Manufacturing staff and QA Change Control to contribute to comprehensive implementation plans for CRs. Product Change-Over. Work with Manufacturing leadership and staff to coordinate and organize product change-over activities and recommend future improvements. Acquire fundamental knowledge of technical aspects of Media/Buffer Prep, Cell Culture and Purification operations. Comply with cGMP Documentation & Operations. Compliance with safety guidelines. Qualifications/Skills: Experience in a GMP regulated environment, with exhibited knowledge or proficiency in a compliance or quality role. Experience leading and implementing projects. Demonstrated ability to influence peers and teams with no direct reporting lines. Ability to speak, present data, and defend approaches in front of a variety of audiences. Organizational skills to contribute to department and cross-functional projects. Familiarity with FDA & European GMP’s and regulatory requirements, guidelines, and recommendations. Strong proficiency with Trackwise. Technical writing must be at a high level with proficient spelling, grammar, and typing skills preferred. Proficiency with standard office software applications, including MS Word, MS Excel, MS Project, MS Power Point. Experience and proficiency with other applications. BA or BS in a technical discipline (physical or biological sciences preferred but not required. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

2038 days ago