Senior Quality Assurance Specialist: Equipment and Systems Qualification

1 week ago

Waterford, Waterford, Ireland beBeeValidation Full time €70,000 - €95,000
Qualification and Validation Specialist

We are seeking a highly skilled and experienced professional to join our team as a Qualification and Validation Specialist. This is an exciting opportunity for someone who is passionate about ensuring the quality and compliance of equipment, systems, and processes in a pharmaceutical environment.

About the Role:

  • Design, execute, and report on process performance qualifications (PPQs) and validation studies for equipment, systems, and processes.
  • Ensure validation activities comply with health, safety, cGMP, construction, and environmental standards.
  • Provide technical guidance on US FDA and EU validation requirements, particularly for aseptic processing, lyophilization, sterilization, and depyrogenation.
  • Maintain validation documentation throughout its lifecycle.
  • Ensure equipment and systems remain compliant with cGMP standards.
  • Participate in external regulatory inspections.
  • Support the site change control process.

Key Skills and Requirements:

  • Strong analytical and problem-solving skills for troubleshooting validation issues related to projects and process development.
  • Knowledge of process validation regulations, technical transfer practices, and interpretation of guidelines.
  • Familiarity with GAMP, ISPE Baseline guides, and steam/dry heat validation publications (e.g., AAMI-ANSI, PDA, ISO).
  • Understanding of quality management systems and compliance regulations.
  • Proficiency in MS Project and SPC packages is an advantage.
  • Effective communication skills at organizational, team, and individual levels.
  • Ability to execute projects according to plan and meet key performance indicators (KPIs).
  • Degree in Science (e.g., Chemistry, Microbiology, Pharmacy) or Engineering (e.g., Chemical, Mechanical, Electrical).
  • Fluency in English.

Benefits:

  • A comprehensive compensation package that includes a competitive salary, benefits, and opportunities for growth and development.
  • A dynamic and collaborative work environment that fosters innovation and teamwork.
  • The opportunity to work on challenging projects that make a meaningful impact in the pharmaceutical industry.

Others:

  • We are an equal opportunities employer and welcome applications from diverse candidates.
  • Please note that only shortlisted candidates will be contacted for further assessment.

  • Quality Assurance Specialist

    6 days ago

    Waterford, Waterford, Ireland beBeevalidation Full time €60,000 - €80,000

    Job Opportunity:Quality Assurance SpecialistWe are seeking a skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality management and be able to ensure ongoing compliance with relevant standards and regulations.The key responsibilities of this role include:Validation Management: Design, execute, and...

  • Quality Assurance Specialist

    3 days ago

    Waterford, Waterford, Ireland beBeeQuality Full time €40,000 - €60,000

    Job Title: Quality Assurance SpecialistAbout the Role:This position is responsible for ensuring that construction services meet high-quality standards. As a key member of our team, you will play a vital role in monitoring site activity and collaborating with various disciplines to implement quality assurance.The ideal candidate will have experience in a...

  • Quality Assurance Specialist

    1 week ago

    Waterford, Waterford, Ireland beBeeQuality Full time €50,000 - €60,000

    Senior Quality Assurance RoleWe are seeking a detail-oriented professional to join our team in delivering high-quality products across all functions.The successful candidate will be responsible for driving a strong quality culture, ensuring compliance with regulatory requirements, and supporting the quality team in achieving its goals.This is an excellent...

  • Contract Opportunity for Quality Assurance Specialist

    1 week ago

    Waterford, Waterford, Ireland beBeeAutomation Full time €80,000 - €100,000

    Quality Assurance Specialist (Contract Opportunity) A highly experienced Quality Assurance Specialist is required to join our team for a 6 month contract based in Co. Waterford. This will be a contract of 6 months with the potential for further extension and offers hybrid working. Responsibilities: Minimum of 5 years experience in quality engineering...

  • Experienced Quality Assurance Specialist

    1 week ago

    Waterford, Waterford, Ireland beBeeQuality Full time €60,000 - €80,000

    Key Role:We are seeking a skilled Quality Assurance Specialist to support our organization's quality initiatives.Requires minimum of 5 years experience in Quality Engineering with expertise in Automation tools such as CypressPrior experience in Finance, Insurance, or banking industries is highly desirableAbout the Position:This is an excellent opportunity...

  • Senior Quality Assurance Professional

    7 days ago

    Waterford, Waterford, Ireland beBeeQuality Full time €63,000 - €98,100

    Quality Assurance SpecialistThis experienced professional will join a leading organisation on a 6-month contract.The role offers a competitive daily rate, flexible working arrangements, and the strong likelihood of extension beyond the initial term.A minimum of five years' experience in quality assurance or a related field is required.Familiarity with...

  • Qualification & Validation Engineer

    1 week ago

    Waterford, Waterford, Ireland Proclinical Full time

    Ready for a new engineering challenge within a company that bring life-changing treatments to the world? Join our client at the forefront of pharmaceutical innovation and make a differenceProclinical is seeking a Validation Engineer to support new product introductions, equipment qualification, and the site requalification program. In this role, you will...

  • Data Quality Assurance Engineer

    2 weeks ago

    Waterford, Waterford, Ireland beBeevalidation Full time €80,000 - €100,000

    Job SummaryWe are seeking a skilled Validation Specialist to join our team. The successful candidate will be responsible for ensuring the ongoing validation compliance of computerised equipment and systems in sterile products manufacturing.Key Responsibilities:Validate all new computerised equipment, and control systems.Generate validation documentation...

  • Product Quality Assurance Specialist

    2 weeks ago

    Waterford, Waterford, Ireland beBeeQuality Full time €40,000 - €55,000

    Job Title: Quality Assurance SupervisorOverview:This role oversees the efficient coordination of team members to conduct tests determining raw materials, bulk intermediate, and finished product quality. Effective execution involves directing and monitoring the quality assurance process, leading and developing team members.The position ensures behaviors,...

  • Quality Assurance Specialist

    1 week ago

    Waterford, Waterford, Ireland beBeeSolar Full time €60,000 - €80,000

    Job Title: Quality Assurance Specialist - Solar Energy ProjectsWe are seeking an experienced Quality Assurance Specialist to join our team in ensuring the highest quality standards on large-scale solar PV projects.Key Responsibilities:Develop and Implement QA/QC ProceduresConduct inspections and audits to verify compliance and identify areas for...