QA Specialist - C&Q And Validation Activ

Pe Global

Cork

PE Global is currently recruiting for a QA Specialist for a client site in Cork: QA Specialist x 2 positions. Job Purpose. We have an exciting opportunity for a QA Specialist to join our expanding team in Cork to help support the Quality Operations unit. The QA Specialist will be responsible for the following. Managing compliance activities and QA operational activities related to operational project as required by Good Manufacturing Practice (GMP). These activities include, C &Q and Validation activities, Data Integrity and CSV support, change control, non-conformance investigations, compliance auditing, and other related quality system elements. You will have fulfilled the educational requirements for this role and have experience in a similar role within a FDA/EMEA regulated environment. What you’re great at: Excellent interpersonal skills. Ability to operate as part of a team is critical. Customer focus. Innovative. Excellent communication skills both written and verbal. Attention to detail. Good problem solving skills. Results and performance driven. Adaptable and flexible. Integrity, trustworthiness and objectivity. Knowledgeable of FDA/EMEA regulatory requirements. As a QA Specialist, your typical day may include: Supports GMP activities from operational through to Laboratory support programs. Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained. Responsible for implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP. Quality oversight of project activities including but not limited to, C&Q activities and process validation through to commercial manufacture. Participates as a key quality member in inspections and audits by external parties/agencies. Key participant within the QA team in the execution of their duties. Executes the activities of the group within quality to create a synergistic approach to goals and tasks. Domestic and international travel may be required. Be vital: To Bachelors Degree in a scientific/technical discipline required. A minimum of 5 years experience in a quality or compliance role within the biological and/or pharmaceutical industry. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities. Focus on patients and customers at all times. Desirable: Advanced degree (MS, MBA, PhD) preferred. Experience in C&Q, and Process validation. Experience in direct interactions with regulatory agencies during site inspections. Interested candidates should send their CV to Audrey.mccarthy@peglobal.net or call 0214297900. 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.

1926 days ago