QA Specialist

Job Description

About PSC Biotech

Who are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

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

Overview

• Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties.
  
• Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
  
• Participate as a functional expert in the cross-functional team responsible for introducing products and materials at Carlow.
  
• Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
  
• Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
  
• Review documentation associated with new product and material introduction, such as Material Packs, QC Test Specifications, BOMs, and MES documentation.
  
• 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 at Carlow.
  
• Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions.
  
• 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.
  

Requirements

• A minimum of 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
  

Qualification & Education 

A Bachelor's degree or higher in a related Science discipline is preferred.

Requirements
Bring energy, knowledge, innovation and leadership to carry out the following: Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes. Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones. Support implementation and training for site Quality Systems and site GMP readiness activities. Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility. Support other QA colleagues, as required. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture. Support gathering of site metrics Ensure the escalation of risks to management in a timely manner.

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