Quality Systems Validation

4 weeks ago


Waterford, Ireland Sigmar Recruitment Full time

Leads team and provides support for new product introduction, new equipment and computer system introduction in line with regulatory requirements, corporate policies and site SOP’s.

Collaborates with both local and global project teams to assure quality of all validation activities performed at site to support release of medicinal products.

Sets priorities of team to ensure all validation activities are planned.

Coordinates and supervises team to ensure maintenance of validated status of site WRT Cleaning/packing/process validation/temperature mapping.

Provides coaching to team members to achieve individual and site goals.

Ensures planning schedules are met in order to achieve customer service.

Performs audit and inspection readiness preparation to meet HPRA, FDA, Regulatory requirements. Provides support in resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.

Performs Quality review of documents.

Background:

  • Thirs level degree in Pharmaceutical / Life Sciences
  • Experience managing teams.
  • Experience in a pharmaceutical Validation, Regulatory or QA environment.
  • Experience of Regulatory inspections and customer audits.
  • IndepthknowledgeandunderstandingforinterpretationofcGMPsand Regulatoryrequirements.
  • Goodknowledgeofreportwriting,ProjectManagement,Continuous Improvementandproblemsolvingtools.
  • Understanding of production and laboratory systems to effect judgementdecisionsconsistentwithqualityandbusinessneeds.
  • Knowledgeandunderstandingofvalidationrequirementsfrom process/cleaning/packing/facilityaspects/systems.
#J-18808-Ljbffr

  • Waterford, Ireland Teva Pharmaceuticals Full time

    Who we areWe touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point.  We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world. We would like to invite applications for the role of Senior...

  • Validation Engineer

    3 days ago


    Waterford, Ireland Proclinical Full time

    Proclinical are seeking a dedicated Validation Engineer to ensure the ongoing validation and compliance of equipment, systems, and processes in a healthcare manufacturing environment.Responsibilities:- Design, execute, and report on validation studies for equipment, systems, and processes.- Provide technical interpretation and guidance on current US FDA and...

  • Validation Engineer

    2 days ago


    Waterford, Waterford, Ireland Proclinical Full time

    Proclinical are seeking a dedicated Validation Engineer to ensure the ongoing validation and compliance of equipment, systems, and processes in a healthcare manufacturing environment.Responsibilities:- Design, execute, and report on validation studies for equipment, systems, and processes.- Provide technical interpretation and guidance on current US FDA and...

  • Automation Engineer

    4 weeks ago


    Waterford, Ireland Bausch & Lomb GmbH Full time

    Select how often (in days) to receive an alert: Location: IE - Waterford, Ireland - All, IE Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on making people see better to live better. The company has a 40-year track record of growth and diversification in Waterford – Ireland’s oldest city. From...


  • Waterford, Ireland Teva Pharmaceuticals Full time

    Who are we?We touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point. We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world. We would like to invite applications for the role of IT Business...

  • Principal Engineer

    4 weeks ago


    Waterford, Ireland Bausch & Lomb GmbH Full time

    Select how often (in days) to receive an alert: Location: IE - Waterford, Ireland - All, IE Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on making people see better to live better. The company has a 40-year track record of growth and diversification in Waterford – Ireland’s oldest city.  From...

  • Facilitator QC

    1 week ago


    Waterford, Ireland Teva Pharmaceuticals Full time

    Who We AreWe touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point. Yet until today, you may not have heard of us. We’re Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world and we currently...

  • Security Supervisor

    4 weeks ago


    Waterford, Ireland Apleona HSG Facility Management Full time

    Advert Text Overall Purpose of the Job An enthusiastic and efficient Team Lead is required to work for our client. The role is to lead the day-to-dayoperation of security services across the contract and to ensure a high quality of service is delivered at alltimes. Main duties and responsibilities Responsible for the day-to-day management and...

  • Mechanical Engineer

    2 weeks ago


    Waterford, Ireland Weltec Engineering Full time

    Weltec Engineering is a dynamic and innovative company at the forefront of engineering solutions. With a commitment to excellence, we specialize in delivering top-quality projects across various industries.We are currently seeking an experienced and motivated Mechanical Engineer to join our team in our head office in Waterford, overseeing projects in the...

  • Site Microbiologist

    4 weeks ago


    Waterford, Ireland Sigmar Recruitment Full time

    I'm currently recruiting a Site Microbiologist for an excellent Waterford based pharmaceutical. This is a permanent role with strong salary package and the chance to join a high performing team. The Site Microbiologist is responsible for the Management of the Microbiology Lab and defines the microbiology strategy for the site in order to meet the...

  • Security Supervisor

    4 weeks ago


    Waterford, Ireland Apleona UK Full time

    The details for the selected vacancy are shown below. Advert Title Security Supervisor - Waterford, Ireland Advert Text Overall Purpose of the Job An enthusiastic and efficient Team Lead is required to work for our client. The role is to lead the day-to-dayoperation of security services across the contract and to ensure a high quality of service is...

  • Site Microbiologist

    4 weeks ago


    Waterford, Ireland Teva Pharmaceuticals Full time

    Who we are We touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point.  We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world. We would like to invite applications for the role of Site...

  • Mechanical Engineer

    2 weeks ago


    Waterford, Ireland Suir Engineering Full time

    Location: On site / Waterford, Ireland job type: Permanent / Full-time Sector and subsector: Engineering | Mechanical Salary: Competitive Salary Weltec Engineering is a dynamic and innovative company at the forefront of engineering solutions. With a commitment to excellence, we specialize in delivering top-quality projects across various...


  • Waterford, Ireland Teva Pharmaceuticals Full time

    Who we are We touch the lives of over 200 million patients every day, and billions every year. After all, everyone needs healthcare or medication at some point. We're Teva, a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world. We would like to invite applications for the role of Manufacturing...

  • Project Engineer

    4 weeks ago


    Waterford, Ireland Bausch & Lomb GmbH Full time

    Select how often (in days) to receive an alert: Location: IE - Waterford, Ireland - All, IE Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on making people see better to live better. The company has a 40-year track record of growth and diversification in Waterford – Ireland’s oldest city.  From...

  • Program Manager

    4 weeks ago


    Waterford, Ireland Jabil Circuit Full time

    JOB SUMMARY The Program Manager manages all phases of programs from inception through completion, ensuring projects are completed on time and within budget. Responsible for the pricing, schedule and technical performance of programs or subsystems of major programs. Manages the overall manufacturing effort of the facility through the coordination and...


  • Waterford, Ireland Teva Pharmaceuticals Full time

    Who we areTeva is a global pharmaceutical leader and the world's largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide. Our employees are at the core of our success, with colleagues in over 80 countries delivering the world's largest medicine cabinet to 200 million people every day....


  • Waterford, Ireland Manguard Plus Ltd Full time

    The CompanyManguard Plus is one of Ireland's leading private security service providers, offering clients professional solutions to their security needs. With offices in Dublin, Kildare, Waterford, Derry, Belfast and London.Due to our continued expansion, Manguard Plus are seeking applications from dynamic, professional security officers for the Full time/...

  • Automation Engineer

    1 week ago


    Waterford, Waterford, Ireland TN Ireland Full time

    Job Description Automation Engineer - County Waterford Ref No: AM18147x County Waterford, Republic of Ireland Competitive salary Automation Engineer - County WaterfordJob summary:The Automation Engineer monitors the quality and efficiency performance of assigned product lines and provides support in driving continuous improvement through process development,...


  • Waterford, Ireland Bausch & Lomb GmbH Full time

    Select how often (in days) to receive an alert: Location: IE - Waterford, Ireland - All, IE Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc., is solely focused on making people see better to live better. The company has a 40-year track record of growth and diversification in Waterford – Ireland’s oldest city. From...