QA Specialist

Jazz Pharmaceuticals

Athlone, Ireland

Responsibilities

This is a key role in the achievement of Jazz business objectives for the Jazz Development and Manufacturing facility. The QA specialist is a key member of the team tasked with successful day-to-day implementation of the Quality Management System (QMS) for the facility as well as supporting other organisational objectives. The QA Specialist will be responsible for operational and compliance support for manufacturing operations, inlcuding review and approval of associated manufacturing and testing records. In addition they will help maintain the site compliance program, supporting the supplier qualificiation program through supplier audits and site compliance through internal audits. The QA specialist will also represent quality on cross-functional and/or cross-company teams for business critical development projects.

Essential Functions

  • Impelment and oversee the quality systems ensuring compliance with all relevant regulatory guidelines and Jazz policies and strategies;
  • Represent Quality during manufacturing operations and be available to resolve issues and provide guidance in a collaborative fashion;
  • Provide quality and cGMP input and oversight of the manufacturing facility including data integrity;
  • Generate QMS Standard Operating Procedures (SOPs) to reflect these processes, which are easy to follow and promote both compliance and efficient operations, in accordance with facility requirements;
  • Review and approve procedures, documents and records (e.g. Specifications, Batch Records, Validation data, QC data, etc.) in accordance with the facility requirements;
  • Review and approve technical support documentation. (Examples include cleaning, process, method validation);
  • Generate and approve Quality documents (e.g. Annual Product Reviews, Licence variations etc.);
  • Support the Deviation and OOS investigation systems, advising on assessing impact and approving final reports and associated CAPA;
  • Support the site change control system, evaluating proposed change controls as assigned, making informed assessments of quality impact of changes;
  • Support the facility Supplier Management program, including qualifications and re-qualifications of suppliers and materials, auditing vendors and providing oversight as required;
  • Manage the QA responsibilities of external manufacturers of APIs, reviewing deviations and changes at the CMO site;
  • Support site compliance program, performing internal audits, training internal auditors as required, and implementing audit action plans;
  • Participate and follow-up in third party audits and/or inspections carried out at the site by the authorities or clients;
  • Complete all required QMS assignments (CAPAs, investigations, actions etc) in accordance with agreed timelines;
  • Perform production on the line AQLs, and the incoming inspection and disposition of raw materials, consumables, packaging;
  • Assist in preparation and presentation of GMP training programmes;
  • Participate in initiatives and action plans for the development of QA and improvement of GMP compliance;
  • Involved in site-wide projects and continuous improvement processes.

Required Knowledge, Skills, and Abilities

  • 5 -10 years experience working in finished product pharmaceutical/biologics manufacturing, including analytical chemistry, quality assurance, quality control, development, and/r manufacturing areas;
  • Excellent working knowledge of quality systems, FDA and EU regulations, cGMPs and ICH guidelines;
  • Demonstrated capability in establishing collaborative working relationships at all levels, regardless of seniority;
  • Possess fundamental scientific thought processes and demonstrated ability to apply this to overcome problems. An ability to think strategically and be a ‘go-to’ expert across the business in area of expertise;
  • Recognize areas for improvement, and use initiative to implement change programs in support of progress;
  • Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment;
  • Ability to deliver objectives on time, every time, while meeting all compliance and cost targets;
  • Ability to generate documentation which is of a high standard;
  • Posess good organizational skills and attention to detail;
  • Posess good written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally;
  • Ability to handle and prioritize multiple assignments, changing priorities and meet deadlines;
  • Promote strong personality with positive attitude and approachable;
  • Demonstrated expertise in the area of Data Integrity highly desirable;
  • Experience in participation in regulatory audits (HPRA or FDA) desirable;
  • QC analytical experience desirable;
  • Computer skills i.e., Microsoft Office, Windows etc. Experience in Reliance, LIMS & SAP would be advantagе;
  • Promote strong personality with positive attitude and approachable.

Required/Preferred Education and Licenses

  • BSc in science discipline required;
  • Lead auditor certification highly desirable;
  • Qualified Person experience or educational requirements desirable.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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