QA Specialist - Regulatory

Pe Global

Cork

PE Global is currently recruiting for a QA Specialist for a client site in Cork: QA Specialist - Regulatory (39 hours per week) 6 months. Position Summary: This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at clients site as required by Good Manufacturing Practice (GMP). These activities include Batch release, Change control, Event management and Annual product review activities. Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met. GENERAL SCOPE OF RESPONSIBILITIES : Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the Standard of Leadership behavior model. Partners with other Departments to ensure that compliance systems are implemented in an efficient manner. Duties • Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints. • Carries out tasks related to the management of batch records design and approval. • Carries out administration of the SAP Quality Management Module. • Carries out tasks relating to the management of site change control systems. • Compiles Annual Product Reviews. • Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.). • Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance. • Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site. • Perform GMP audits on-site and vendor facilities as required. Key Skills and Competencies required: • 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. • Decision making. QUALIFICATIONS AND EXPERIENCE: ESSENTIAL- Quality Assurance Specialist-QA Operations: • Bachelor’s Degree in a scientific/technical discipline required. • A minimum of 3-5 years’ experience in a quality, validation 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 as they apply to quality, including those of FDA, IMB, EMEA and other authorities. DESIRABLE: • Experience in auditing of external suppliers, contractors and vendors. 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.

1988 days ago