▷ (Only 24h Left) Qualified person

1 day ago

Cork, Ireland Gilead Sciences, Inc. Full time

For Current Gilead Employees and Contractors:

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 biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies.

As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives.

You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

We are looking for a Qualified Person to join our team in Cork.

Essential Functions:

- Complies with the responsibilities of Qualified Person (QP) stated in directives issued by EC. Certifies batches for sale or supply in compliance with regulations.
- Release of Investigational medicinal Products in accordance with the requirements of Annex 13.
- Approves Annual Product Quality Review, SOPs, Complaint investigations, Deviations (EQMS general investigations).
- Attends and participates Event Review, Quality Systems Review and Site QP Meetings.
- Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.
- Participates in writing or suggesting changes to controlled documents (e.g., SOPs, Specifications, Methods, etc.) as needed to ensure defined quality objectives are met.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
- Reviews manufacturing, environmental monitoring and quality control data for in-process and finished products.
- Works closely with operating entities to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis to enforce requirements and meet specifications.
- May participate in the writing of annual product reviews and the development of training programs regarding all aspects of producing quality products.
- May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.
- Works with Research and Development during new product start-ups, and establishes key checkpoints for new products and processes.
- May assist or lead compliance audits as required.
- May interface with regulatory agencies as required. Interfaces with contract manufacturers to address documentation and compliance issues.
- Proficient in Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs).

Knowledge, Experience & Skills:

- Proficient in application of QA principles, concepts, industry practices, and standards. Demonstrates ability to effectively manage multiple projects/priorities.
- Proven analytical and conceptual skills.
- Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes.
- Demonstrates excellent verbal communication, technical writing and interpersonal skills. Demonstrates working knowledge with good proficiency in Microsoft Office applications.
- Must meet the minimum requirements for education and experience as outlined in Directive 2001/83/EC relating to medicinal products for human use.
- Some years of relevant experience in the pharmaceutical industry and a BS or BA or relevant experience and a MS.
- Working knowledge of risk management tools (e.g., Hazard Analysis and Critical Control Points (HACCP) and / or Failure Mode Effects Analysis (FMEA)) is beneficial.
- Knowledge of Six Sigma, Define-Measure-Analyze-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical is beneficial.

Company Profile

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual’s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

#J-18808-Ljbffr

  • ▷ [Only 24h Left] Part Qualified Accountant

    1 week ago

    Cork, Ireland Hays Specialist Recruitment Ireland Ltd Full time

    Your new company An exciting opportunity opened in Little Island for a Part-Qualified Accountant. Your new role Processing all bank transactions and preparing bank reconciliations for our NI operations. Assisting in the preparation and submission of tax and VAT returns. Preparation of accounts to trial balance stage. Month-end balance sheet reconciliations....

  • (Only 24h Left) Packaging Technician

    1 week ago

    Cork, Ireland Catalyx Full time

    Catalyx is seeking a Packaging Technician to join our team and work on our customer site in Cork on a short term contract. 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...

  • Junior QA Manager

    5 days ago

    Cork, Ireland Motorola Solutions Full time

    At Motorola Solutions, we're guided by a shared purpose - helping people be their best in the moments that matter - and we live up to our purpose every day by solving for safer. Because people can only be their best when they not only feel safe, but are safe. We're solving for safer by building the best possible technologies across every part of our safety...

  • [Only 24h Left] Customer Success Engineer

    5 days ago

    Cork, Ireland NetApp, Inc. Full time

    Job Summary As customers today increasingly invest and engage in more flexible consumption models, Customer Success plays an increasingly critical role in helping customers shorten the time to value, getting our products sticky and accelerating their business outcome. The Cloud Consumption Customer Success organization plays a critical role with NetApp’s...

  • Payroll Specialist

    1 week ago

    Cork, Ireland PE Global Full time

    About the company: We are a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Our therapeutic areas of focus include...

  • [Only 24h Left] Site Manager

    1 week ago

    Cork, Ireland Global Professional Consultants Full time

    Site Manager A well-established leading Main Contractor in Cork is seeking a Site Manager to work on a Pharmaceutical Project. Role: Site manager will collaborate closely with the onsite team, including subcontractors, engineers, and management, to coordinate and manage all onsite activities. Planning and supervising the setup of the site, ensuring that...

  • Only 24h Left! Possession Planner

    7 days ago

    Cork, Ireland Gilbride Management Group (GMG) Full time

    Excellent Salary + Benefits Include: Excellent Salary + Benefits Include: Pension, Contributed Healthcare, Life Assurance,plus many flexible benefits. At Alstom, we understand transport networks and what moves people. From high-speed trains, metros, monorails, and trams, to turnkey systems, services, infrastructure, signalling and digital mobility, we offer...

  • Qualified Accountant – Cork

    1 week ago

    Cork, Ireland GPC Finance Full time

    GPC Finance are delighted to partner with a progressive firm in Cork looking for aQualified Accountant. For more than 20 years my client has gained substantial experience from a broad range of sectors. ThisQualified Accountantwill not only advise their clients, but will become a business partner to them. - Preparation of financial statements for Limited...

  • Only 24h Left! QA Associate

    1 week ago

    Cork, Ireland BioMarin International Limited Full time

    Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...

  • (Only 24h Left) SHO Urology

    1 week ago

    Cork, Ireland hospital.ie Full time

    We are currently accepting applications for SHO's in Urology: A fantastic opportunity to progress your career for suitably qualified doctors. Essential requirements: 1. Registered with Irish Medical Council (IMC) 2. Relevant Clinical Experience (relevant post qualification experience & training) 3. Excellent communication skills - IELTS/OET if...

  • Maintenance Planning Engineer

    1 week ago

    Cork, Dublin, Ireland Gas Networks Ireland Full time

    Gas Networks Ireland operates and maintains Ireland’s €3bn, 14,725km national gas network, which is considered one of the safest and most modern renewables-ready gas networks in the world. Almost 725,000 Irish homes and businesses trust Ireland’s gas network to provide efficient and reliable energy to meet their heating, cooking, manufacturing and...

  • Only 24h Left! Manufacturing Process Specialist

    1 day ago

    Cork, Ireland Johnson & Johnson Full time

    Job Description - Manufacturing Process Specialist (2506232529W) Johnson & Johnson Innovative Medicine is currently seeking a Manufacturing Process Specialist to join our operations team located in Cork, Ireland. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases...

  • (Only 24h Left) Data Lead, Manager

    3 days ago

    Cork, Ireland Gilead Sciences, Inc. Full time

    For Current Gilead Employees and Contractors: 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...

  • ▷ (Only 24h Left) Automation Support Engineer

    1 week ago

    Cork, Ireland Cognizant Full time

    Automation Support Engineer - Cork, Site Based Zenith Technologies, now a Cognizant Company is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimised to improve operational efficiencies, whilst maintaining...

  • ▷ Only 24h Left: Java developer

    5 days ago

    Cork, Ireland Endeavour Recruitment Solutions Full time

    JUser: :_load: Unable to load user with ID: 994 Job Summary - Country: Ireland - Location: Cork - Sector: Software Developer - Daily Rate: Euro €340 - Job Type: Contract Endeavour Recruitment has an excellent new opportunity for a Java Developer to work for a specialist client in the Software Development sector in Cork, Ireland. The duration of this...

  • [Only 24h Left] Transport Coordinator

    1 week ago

    Cork, Ireland DP World Full time

    Are you an experienced Transportation Coordinator looking for a new opportunity? Are you interested in joining a dynamic company with a strong growth plan? Right now is a great time to join the DPWorld team! We are looking for a Transport Coordinator to cover a 9-12 month contract in our Technology business based in Cork, Ireland. About the Role How you...

  • IT Software Developer, Senior

    1 week ago

    Cork, Ireland Qualcomm Full time

    Company: Qualcomm Incorporated Job Area: Information Technology Group, Information Technology Group > IT Software Developer General Summary: Specific to this role, we are looking for individuals with programming experience focused on interacting with databases, Rest APIs, and automation frameworks. With a large and complex environment, we are looking...

  • Project Engineer

    18 hours ago

    Cork, Ireland PE Global Full time

    PE Global is currently recruiting for a Project Engineer for a leading multi-national pharmaceutical clients based in Cork. This is an initial 12-month contract position. As part of the Engineering Project Delivery Team, this contract position is responsible for all activities required to support project scoping, commissioning, qualification, validation and...

  • Only 24h Left: Director, Drug Product Technology Transfer

    1 week ago

    Cork, Ireland BioMarin International Limited Full time

    Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a...

  • Only 24h Left! Registered Nurse

    7 days ago

    Cork, Ireland Irish Blood Transfusion Service Full time

    Post 1869 Registered Nurse Platelet Apheresis Department Cork Centre Part-time (112.5hrs over 4 weeks) Temporary Specified Purpose Cork Centre at located at St. Finbars Hospital, Cork The IBTS is currently recruiting a Registered Nurse part-time, temporary specified purpose, based in the Platelet Apheresis Department at our Cork Centre. The Irish Blood...