QA Specialist-Hybrid

PSC Biotech Corporation; Carlow; Hybrid; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Hybrid work pattern

Job summary

PSC Biotech Corporation in Carlow, Ireland, is seeking a Quality professional with 3–5 years in a pharmaceutical quality role to join our hybrid on-site team. You will manage quality agreements, review documentation for new products, and support deviations and CAPA activities to ensure compliant processes.

You'll work across supplier management, participate in plant quality committees, and drive improvements with cross-functional teams in a dynamic environment.

Qualifications

• 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
• Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
• Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.
• Strong report, standards, and policy writing skills.
• Experience with equipment and process validation.
• Familiarity with sterile filling processes and equipment.
• Proficiency in Microsoft Office and job-related computer applications.
• Experience or familiarity with Lean Six Sigma methodology is desired.
• Good collaboration skills and the ability to work effectively as part of a team to determine priorities.
• Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance.
• Proven ability to drive the completion of tasks.
• Strong decision-making capability with a sense of accountability and responsibility.
• Demonstrated problem-solving skills

Responsibilities

• Quality Agreement management & APR Quality Agreement Chapter owner
• Review documentation associated with new product and material introduction, such as Material Packs, QC Test Specifications, BOMs, Supplier Qualification and Oversight.
• Develop and monitor supplier performance metrics, participate in material review boards and quarterly reviews of key suppliers, and actively engage in cross-functional forums as needed.
• Maintain the approved supplier management list within the qualified Supplier Management system, ensuring correct setup of suppliers and materials used.
• Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions.
• Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties including periodic re-evaluations.
• Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
• Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements. Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency. Actively participate in Plant/Quality committees and collaborate with other site functional groups.
• Participate as a functional expert in the cross-functional team responsible for introducing products and materials.

Skills

Quality Assurance

cGMP Knowledge

GDP Knowledge

Regulatory Standards

Documentation Skills

Lean Six Sigma

Cross-Functional Collaboration

Independent Worker

Decision Making

Problem Solving

Education

Bachelor’s degree in related science

Tools

Microsoft Office

Job description

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Carlow
• State/Province Carlow
• Country Ireland

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.

Role Functions:

• Quality Agreement management & APR Quality AgreementChapter owner
  
• Review documentation associated with new product andmaterial introduction, such as Material Packs, QC Test Specifications, BOMs,Supplier Qualification and Oversight.
  
• Develop and monitor supplier performance metrics,participate in material review boards and quarterly reviews of key suppliers,and actively engage in cross-functional forums as needed.
  
• Maintain the approved supplier management list within thequalified Supplier Management system, ensuring correct setup of suppliers andmaterials used .
  
• Support deviation and atypical closeout, as well asinitiate and follow up on corrective and preventive actions.
  
• Provide quality oversight and direction for theintroduction of new products and materials, as well as manage external partiesincluding periodic re-evaluations.
  
• Author, review, and approve protocols and reports fortechnology transfer, method qualification, and method validation.
  
• Facilitate compliance direction for the site by adheringto divisional policies, guidelines, and regulatory requirements. Proactivelyevaluate site compliance against emerging trends and initiate major complianceinitiatives for improved status and operational efficiency. Activelyparticipate in Plant/Quality committees and collaborate with other sitefunctional groups.
  
• Participate as a functional expert in thecross-functional team responsible for introducing products and materials .
  

Requirements

Experience, Knowledge & Skills:

• A minimum of 3-5 years of experience in a quality role,ideally in a pharmaceutical manufacturing environment.
  
• Knowledge of regulatory/code requirements related toIrish, European, and International Codes, Standards, and Practices.
  
• Familiarity with cGMP (current Good ManufacturingPractice) and GDP (Good Distribution Practice) is preferred.
  
• Strong report, standards, and policy writing skills.
  
• Experience with equipment and process validation.
  
• Familiarity with sterile filling processes and equipment.
  
• Proficiency in Microsoft Office and job-related computerapplications.
  
• Experience or familiarity with Lean Six Sigma methodologyis desired.
  
• Good collaboration skills and the ability to workeffectively as part of a team to determine priorities.
  
• Demonstrated ability to work independently and takeownership of improvement initiatives with a moderate level of guidance.
  
• Proven ability to drive the completion of tasks.
  
• Strong decision-making capability with a sense ofaccountability and responsibility.
  
• Demonstrated problem-solving skills
  

Qualifications & Education:

• A Bachelor's degree or higher in a related Sciencediscipline is preferred.
  

Additional Notes:

• Hybrid, usually 2/3 days per week on site