Catalyx | QA Specialist | Packaging

5 days ago


Cork, Ireland Catalyx Full time

Catalyx is seeking a QA Specialist to join our team and work on our customer site in Cork. The QA Specialist is responsible for the creation, revision, and delivery of GMP documentation to our FDA-regulated customers. Who We Are: Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processesgloballywith a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies joined forces. For over three decades, Catalyxs partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety. To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit. The Role: Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organisations, to empower them to enhance efficiency, and drive success. As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations. Responsibilities: Deliver Quality Assurance support to the Packaging Department. Evaluate and approve GxP documentation. Conduct Batch Record Review and Batch Disposition processes. Update Quality Assurance Standard Operating Procedures (SOPs) as necessary. Scan and archive documents as needed. Inspect finished products. Perform investigations into deviations and conduct Root Cause Analysis. Generate reports for customer complaints. Conduct line clearance for packaging areas. Suggest process enhancements and recommend changes. Assist with internal and regulatory audits/inspections as required. Support the training and mentoring of new employees. Provide additional support and assistance on tasks and projects as directed by management. Collaborate with cross-functional teams. Achieve agreed-upon KPIs and metrics. Perform other duties as necessary. Skills and Experience: A relevant third-level qualification in a QA discipline. A minimum of 2-3 years of relevant industrial experience in a QA role, preferably in the pharmaceutical sector. Experience with Batch Record Review in Pharma/Med Devices is essential. Demonstrable understanding of Document Control principles, Quality Systems, and GMP requirements. Comprehensive knowledge of document control processes and the relationship between document change processes and products. Familiarity with the current pharmaceutical industry and relevant regulations, including 21 CFR, GxP, and ICH guidelines. Proficiency with Electronic Document Management Systems (EDMS). Stay informed about compliance requirements in your work area. Exhibit strong problem-solving skills with attention to detail. Proficiency in Microsoft Office applications and experience with Oracle. Excellent written and verbal communication skills, coupled with strong interpersonal skills. A proactive attitude toward customer service and performance. Why Join Catalyx? At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities. Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported. We do not discriminate on the basis of race, colour, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, veteran status, genetic information, or any other characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create a welcoming environment for everyone. At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates


  • Senior Specialist QA

    2 months ago


    Cork, Ireland Stryker UK Limited Full time

    Work Flexibility: Hybrid QA Senior Specialist, UK & BNN Group: RAQA Division: EMEA Location: UK/Nordic/Benelux Position Summary Develops and applies sound knowledge and understanding of the QA frameworks, legislative requirements, processes and procedures in the EMEA distribution organisation. Responsible for developing and maintaining the QMS and...

  • QA Specialist

    6 months ago


    Cork, Ireland Westbourne IT Global Services Full time

    Essential Duties and Job Functions: ·Participates within inter-departmental and cross-functional teams ·Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements Reviews routine release documentation for Packaging Components & Starting Materials Reviews Supplier investigations, Temptales and disposal of...


  • Cork, Ireland BioMarin Full time

    Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled...


  • Cork, Ireland RT Lane Ltd Recruitment Full time

    R.T. Lane Recruitment are currently recruiting for a QA Specialist Quality Systems to work with a Pharmaceutical Company in Cork. This is an 11-month contract with strong potential for extension. **Please note that candidates must hold the correct working visa for Ireland as my client cannot offer visa assistance and must be already residing in Ireland** **...


  • Cork, Ireland BioMarin Full time

    Who We Are For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled...

  • QA Specialist

    7 months ago


    Cork, Ireland Westbourne IT Global Services Full time

    Main Purpose and Objectives of Position: ·Provide Quality leadership, direction and governance for the specific area of responsibility. ·Manage quality-related matters specific to area of responsibility ·Responsible for approving appropriate quality-related documents. Approval signature confirms that company and GMP requirements have been met. ...


  • Cork, Ireland Gilead Sciences Full time

    Job Description At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s...


  • Cork, Ireland Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. At Eli Lilly Cork, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 41,000 employees around the world work to discover and bring life-changing...

  • AML QA Specialist

    6 months ago


    Cork, Ireland Amazon Ireland Support Services Limited - A94 Full time

    The AML Programme team in Registration and Compliance (R&C, part of Selling Partner Risk) is looking for a Portuguese-speaking quality control specialist to join a team of quality specialists covering the Know Your Customers programme. The role is critical to ensure that Amazon’s payments businesses expand with appropriate controls and quality processes in...


  • Cork, Ireland Amazon TA Full time

    The Compliance Quality team in Registration and Compliance (R&C, part of Selling Partner Risk) is looking for a German-speaking quality control specialist to join a team of quality specialists covering the Denver Audit the Auditor programme. The role is critical to ensure that Amazon’s payments businesses expand with appropriate controls and quality...


  • Cork, Ireland Westbourne IT Global Services Full time

    This experienced position requires requiring sound knowledge of quality assurance systems, methods and procedures. The candidate will lead product complaint investigations including coordinating the different investigation elements with site departments, completing detailed review of complaint samples against master files to determine authenticity,...

  • QA Engineer

    6 months ago


    Cork, Ireland Attitude Technologies Full time

    Who we are Attitude Technologies was founded in January 2017 based in Cork. The mission of Attitude Technologies LTD is to offer high-quality, innovative and moderately priced smart collars which gives our customers a deep understanding of their pet’s daily life. We also aim to offer an online-veterinarian platform which builds up a...


  • Cork, Ireland NetApp Full time

    Title: Snr HR Operations Specialist Location: Cork, Munster, IE, T23 PPT8 Requisition ID: 128334 Job SummaryAre you ready to take on a pivotal role that puts you at the heart of our organization's HR support and services? We're seeking a talented individual to join our team as an HR Support Specialist, where you'll have the opportunity to make a...


  • Cork, Ireland Jones Engineering H.A. O'Neill Full time

    Position: Electrical Contracts Manager Location: Cork Office / Onsite Company Description We are a leading engineering services company with a proven track record of high quality, customer focused project delivery for over 130 years. Our core divisions include Mechanical Engineering, Electrical Engineering, Sprinkler and Fire Protection. Some of the other...


  • Cork, Ireland Endo Operations Limited Full time

    Description The Senior Quality Specialist, Quality Operations has responsibility for overseeing quality in Contract Manufacturing Quality Operations and Quality Management Systems (all aspects), as well as handling Corrective and Preventive Actions (CAPA). May manage projects or serve as a designee to the Subject Matter Expert (SME) or Process Owner...


  • Cork, Ireland Upliftinlife.com Full time

    Description and Requirements Location: onsite in Cork office, Ireland Hours of operation: current shift: 8.00am to 4.30 pm, 5 days a week across the full week (Mon-Sun) but subject to change Salary: 31,500 gross per annum + 1000 gross sign on bonus + performance bonus We offer up to 4 weeks accommodation for candidates relocating from outside of Ireland If...


  • Cork, Ireland Amazon TA Full time

    Our overall mission is simple: We want Amazon to be the place where our customers can find, discover and buy anything online. Whatever our customers want, we will find the means to deliver it. With your help, Amazon will continue to enable people to discover new worlds. This is your chance to make history. We believe passionately that employing a diverse...


  • Cork, Ireland Upliftinlife.com Full time

    For our client we are looking for Sales Specialists:  Location: Onsite in Cork, Ireland (free car park, onsite gym, subsidized canteen). Permanent position Hours of operation: no weekend work, Monday - Friday across 8am- 4:30pm Salary: 32,250 gross p/a + 1000 gross sign on bonus + Uncapped Monthly Commission Sales Specialists manage WARM leads (as the...


  • Cork, Ireland Recruitment by Aphex Group Full time

    Purpose The role requires the individual to perform a series of tasks to guarantee the quality of our products and processes, and adherence to the Quality Management system. The responsible person will contribute to the organisation of quality control and process validation activities as well as interacting with various stakeholders in the business. This is...


  • Cork, Ireland Cloudera Full time

    Job Description :  At Cloudera, we empower people to transform complex data into clear and actionable insights. With as much data under management as the hyperscalers, we're the preferred data partner for the top companies in almost every industry. Powered by the relentless innovation of the open source community, Cloudera advances digital transformation...