Job Description
R.T. Lane Recruitment are currently recruiting for QA Specialists to work with a pharmaceutical company based in Cork. This is a 12-month contract with strong potential for extension. **Please note that candidates must hold the correct working visa for Ireland and be currently living in Ireland as my client cannot offer visa assistance** The successful candidate will have responsibility for carrying out tasks and projects related to management of Quality Assurance as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, change control, Event management, Supplier qualification, Annual product review and Validation compliance activities. Duties include but not limited to: Batch Record Review & material release to ensure compliance with GMP requirements. Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints. Carries out tasks relating to the management of site change control systems. Compiles Annual Product Reviews. Supports all validation activities on site as described in the Site Validation Master Plan. Reviews and approve 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. Participates in the introduction of new process or modified process steps, Perform GMP audits on-site and vendor facilities as required. Performs on the floor walkdowns regularly to ensure process and facilities are maintained to GMP standards. Qualifications & Experience: ESSENTIAL Bachelors 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. Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities. Please note due to a high volume of applicants you will only be contacted if suitable for the position. For more information or a full Job Description please contact Michelle Power, R.T. Lane Recruitment on or email Skills: GMP FDA GMP Audits Quality Assurance Quality Management Benefits: Paid Holidays