Quality Auditor - International Travel

Harry Walsh Associates Ltd

Cork

Known for it's pharmaceutical excellence, this company is recognised worldwide for their supply of generic pharmaceuticals with an emphasis on product quality and supply chain.You will be joining a strong dedicated team working together for the common goal of advancing healthcare and patient health. This team prides itself on it's knowledge and skills with extensive experience in U.S. FDA-regulated pharmaceutical manufacturing. As a member of the auditing team youwill be the lead for auditing and associated activities in the CMO sites worldwide,ensuring that licensed pharmaceutical products are manufactured, tested and released in compliance with cGMP, US FDA and other applicable regulations. Your role will be tominimise risk by ensuring a high level of compliance is being adhered to for outsourced work,auditing the associated activities in our CMO sites. This position requires 40% travel worldwide. Responsibilities: Lead and conduct quality inspections of outsourced manufacturing facilities, including, but not limited to, solid dose finished product manufacturing facilities and sterile finished product manufacturing facilities to ensure compliance with cGMP and US FDA regulations. Lead and conduct responsible sourcing inspections of outsourced manufacturing facilities as per company guidelines. Lead and conduct quality inspections of other third party service providers such as packaging sites,API manufacturing facilities and contract laboratories. Compile inspection reports to include findings, corrections and process improvements. Track corrective actions and planned action agreements from inspections to closure. Participate in continuous evaluation and improvement of all quality aspects at manufacturing sites with particular emphasis on process systems and QMS. Carry out business and compliance due diligence exercises. Assist in ensuring compliance policies are managed correctly and efficiently and provide recommendations and direction to relevant parties as necessary. Keep the Management team and colleagues updated on issues and actions which impact the business. Be flexible within the Quality function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience as required. Rewards and Benefits: Contemporary Office Space and Car Parking. Health Insurance. EAP. Defined Contribution pension. Sick Pay Benefit. Life Assurance. Annual Leave - 22 days per annum. Service Awards. Educational Assistance Programme. ESPP Scheme. Cycle-to-Work Scheme. Experience: Educated to degree level or high, minimum B.Sc. (biological or chemical sciences) or B. Eng, (process and chemical. Ideally Lead Audit Certified. Proven External Auditing Experience. 6+ years pharmaceutical manufacturing experience in a similar type role within a progressive multinational organization. Broad knowledge of at least one dosage form e.g. sterile’s/injectables or solid dose manufacturing is important. Experience of laboratory, with considerable expertise in at least one pharmaceutical field. Solid understanding and knowledge of cGMP, Quality Assurance and regulatory principles in a pharmaceutical manufacturing environment including ICH guidelines and CFR part 210 / 211 regulations, 21 CFR Part 11 regulations. Solid understanding of Quality Management Systems. Solid understanding of basic pharmaceutical processes such as a solid dose manufacturing process, aseptic manufacturing processes, packaging process. Next Steps: Apply now by clicking the “Apply” button below. Not quite ready to apply, or have some questions first? Call Evelyn 021 436 8330 to discuss this role in confidence. “Finding the right job for you....your job your location and your salary!” www.hwa.ie. This job originally appeared on RecruitIreland.com.

2445 days ago