QA Chemist

Fastnet The Talent Group

Cork

Role summary: Reporting to the QA Team Leader, an assignment position has arisen within the Quality Assurance Department. The QA Chemist will be committed to continuous improvement, leading initiatives and working with members of the Value Stream to assure high-quality standards. Responsibility: 1. Compliance with ICHQ7. * Review and approval of master batch records and executed batch records to assure compliance with regulatory standards and regulatory filing. * Disposition of intermediates and API. * Review and approval of deviations, change controls, SOPs, out of compliance, laboratory investigations and Post MIs. * Lead /support process, equipment, and cleaning validation. * Ensure all quality systems are implemented/executed in compliance with ICH Q7 and PQS. * Lead periodic audits and reviews of manufacturing operations and quality systems to ensure compliance with cGMPs and other regulatory requirements. * Assist with regulatory inspections. * Assist with the development and delivery of cGMP training. * Review and Approval of Project and Equipment Qualification Documentation. * Revising SOPs and providing training as required. 2. Quality Culture / CI: Develop and promote a strong quality culture focused on RFT, CI and individual accountability. * Lead/support root cause analysis investigations including Pfizer Human Performance (PHP) investigations and quality risk assessments to ensure effective investigations to identify and implement CAPAs within the agreed timeframe. * Execute/support projects to drive quality excellence (using benchmarking as required. * Lead/ support site projects as required. * Work within a process Team/Value stream centered organization in order to achieve high levels of performance and continuous improvement. * Support internal audit program and weekly walk through audits. 3. Batch release (supply): Responsible for batch release lead time enabling on-time production and shipping. * Enable release adherence to the planned production and shipping schedule. * Deliver on target batch review times. 4. Safety: responsible for initiating and investigating SII and completion of safety actions. Requirements. * BSc in Chemistry or equivalent. * Thorough knowledge of GMP's and regulatory expectations for manufacturing of APIs. * Relevant years of experience working in the pharmaceutical manufacturing industry, preferably in Quality or a related Technical function. * The ideal candidate will be a self-starter with the ability to work on their own initiative and within teams. * Strong communication and organizational skills are important with the ability to build relationships internally and externally. * Excellent ability to deliver results, with strong interpersonal and influencing skills. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.

2405 days ago