Principal Quality Assurance Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeQuality Full time €40,000 - €60,000
Senior Quality Assurance Associate Role

About the Job:

This is a unique opportunity to join our client's site as a Senior Quality Assurance Associate, reporting to the QA Manager. As a core member of the site Quality Assurance team, you will be responsible for ensuring adherence to safety standards and SOPs in all activities.

The successful candidate will provide real-time quality oversight and support for production unit operations, extending to formulation, vial and syringe Fill Finish activities, including media fills and assessment of aseptic interventions.

You will conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations. Additionally, you will offer Quality Assurance support for on-the-floor investigations and deviations, review and approve deviations for closure, ensuring compliance with appropriate documentation.

As a key member of the team, you will participate in customer complaint investigations, conduct routine Quality Assurance walks on the production floor, and review and issue logbooks, ensuring compliance with procedures.

You will also provide training and guidance to staff for effective performance, review and approve cGMP records, ensuring compliance with appropriate documentation, and support continuous improvement and Operational Excellence initiatives.

Key Responsibilities:

  • Ensure adherence to safety standards and SOPs in all activities.
  • Provide real-time quality oversight and support for production unit operations.
  • Conduct inspections of vials and syringes as part of AQLs, annual reserve inspections, and support complaint investigations.
  • Offer Quality Assurance support for on-the-floor investigations and deviations.
  • Review and approve deviations for closure, ensuring compliance with appropriate documentation.
  • Participate in customer complaint investigations.
  • Conduct routine Quality Assurance walks on the production floor.
  • Review and issue logbooks, ensuring compliance with procedures.
  • Provide training and guidance to staff for effective performance.
  • Review and approve cGMP records, ensuring compliance with appropriate documentation.
  • Support continuous improvement and Operational Excellence initiatives.

Requirements:

  • Minimum Qualification: Science Degree / Engineering degree
  • Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
  • Excellent written and verbal communication skills.
  • Experience working with dynamic cross-functional teams and proven abilities in decision making.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Demonstrated ability in problem solving particularly in supporting non-conformance/deviation investigations.
  • Experience working in aseptic operations, protein formulation, vial and syringe filling.
  • Knowledge of applicable Regulatory requirements, and ability to evaluate compliance issues.

What We Offer:

A competitive compensation package, opportunities for professional growth and development, and a collaborative work environment.

How to Apply:

Interested candidates should submit an updated CV and cover letter outlining their qualifications and experience.

],

  • Principal Quality Assurance Specialist

    2 days ago

    Dublin, Dublin City, Ireland beBeeAssurance Full time €90,000 - €120,000

    Quality Assurance SpecialistThis position offers a fantastic opportunity to work as a Quality Assurance Specialist.Key Responsibilities:SUPPORT multiple site functional and cross-functional tier structuresReviews and approves CAPAs, change requests, investigative protocols, and final reports for accuracy and completenessFocuses on quality aspects of material...

  • Principal Quality Assurance Specialist

    5 days ago

    Dublin, Dublin City, Ireland beBeeQuality Full time €100,000 - €140,000

    Job Title: Senior Quality Assurance ProfessionalRequired Skills and Qualifications:Minimum of a Bachelor's degree in a relevant technical discipline (ideally Quality, Engineering or Science)8 years' relevant experience in a regulated environment with a core appreciation of FDA regulations and Risk Management incl. writing and/or reviewing Quality related...

  • Senior Principal Water Quality Specialist

    1 week ago

    Dublin, Dublin City, Ireland beBeeWaterQuality Full time €60,000 - €80,000

    Job TitleSenior/Principal Water Quality SpecialistAbout the RoleWe are seeking an experienced Senior/Principal Water Quality Specialist to drive water quality improvement initiatives across Ireland.

  • Quality Assurance Lead

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeQuality Specialist Full time €76,110 - €103,075

    At West, we're dedicated to improving patient lives. Our purpose has been at the center of our organization for over a century.We began our journey when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work delivering life-saving and life-enhancing injectable medicines to...

  • Quality Assurance Specialist

    3 days ago

    Dublin, Dublin City, Ireland beBeeQuality Full time €31,243 - €44,942

    Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for monitoring and enhancing employee performance through coaching on quality and market-specific requirements.Key Responsibilities:Monitor and enhance employee performance through coaching on...

  • Quality Assurance Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeequality Full time €45,000 - €70,000

    Job Title: Quality Assurance SpecialistThe company is seeking a dedicated Quality Assurance Associate to join their team. As a Quality Assurance Associate, you will play a key role in ensuring the quality of products and services.",

  • Quality Assurance Specialist

    6 days ago

    Dublin, Dublin City, Ireland beBeeAssurance Full time €60,000 - €100,000

    Quality Assurance SpecialistAn exciting opportunity has arisen for a Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality of our products and services. ResponsibilitiesDevelop, implement, and maintain quality systems and procedures.Conduct regular audits and assessments to ensure compliance with...

  • Quality Assurance Specialist

    7 days ago

    Dublin, Dublin City, Ireland beBeeAssurance Full time €40,000 - €50,000

    Quality Assurance SpecialistWe are seeking a dedicated Quality Assurance Specialist to play a vital role in ensuring the quality of our products and services. This is an exceptional opportunity for a motivated individual to join our team and contribute to our mission.Key Responsibilities:Develop and implement quality assurance procedures to ensure compliance...

  • Quality Assurance Specialist

    4 days ago

    Dublin, Dublin City, Ireland beBeeQuality Full time €90,000 - €120,000

    Job Title: Quality Assurance SpecialistWe are seeking a seasoned professional to join our team as a Quality Assurance Specialist in Dublin.Key responsibilities include reviewing and approving new and updated documentation for accuracy and compliance with industry regulations.Data integrity is ensured by reviewing production records, such as electronic batch...

  • Quality Assurance Specialist

    2 weeks ago

    Dublin, Dublin City, Ireland beBeeQuality Full time €60,000 - €120,000

    Job Title: Quality Assurance SpecialistJob DescriptionThe Quality Assurance Specialist will be responsible for leading critical projects and managing the company's quality management system to meet international standards. This involves providing leadership to a team, managing validation studies, and working closely with internal and external...