Quality Assurance Specialist Drug Substance Release
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Job Description
About PSC Biotech
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.
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.
The Quality Assurance Specialist role supports the introduction and execution of new products, materials and drug substance into the Carlow facility.
The QA Specialist (NPI / DS / Materials) will participate as a core member of the Technical Transfer Team that manages Vaccine and Biological product development and manufacture, along with day to day QA activities, including:
1. Ensuring that the process for the introduction of biologics/vaccines is in compliance with cGMP and the associated regulatory requirements.
2. Reviewing and approving documentation to support corporate compliance/regulatory expectations for manufacturing.
Role Functions
Provide quality oversight and direction for the introduction of new products, drug substance and materials onto site covering the end to end strategy.
Quality point of contact at both a site level and for all external inputs (Transfer Site QA/QC/ Regulatory), including co-ordination of/attendance at Quality working group meetings.
Participate as functional expert in the cross functional team that manages introduction of products and materials
Performs quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
Authors, reviews and participates in approvals of protocols and reports for technology transfer, method qualifications and method validation.
Review other documentation associated with new product, drug substance and material introduction (Material Packs, QC Test Specifications, BOMs, MES documentation etc.)
Provide quality oversight and direction for Material introduction process and external party management.
Development & monitoring of supplier performance metrics. Actively participates as a member of Material Review Board and Quarterly Business Review of key suppliers, and other cross functional forums as requested.
Maintain the approved supplier management list within the qualified Supplier Management system by ensuring that all suppliers and materials used at Carlow are correctly set up.
Responsible for supporting deviation and atypical close out and initiating/following up on corrective and preventative actions.
Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements. Assist in the proactive evaluation of site compliance against emerging regulatory trends. Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site. Actively participate in Plant/Quality committees and works with other site functional groups, such as the QC, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives.
Requirements
3-5 years experience in a quality role, ideally in a pharmaceutical manufacturing environments.
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
Knowledge of cGMP and GDP preferred
Report, standards, policy writing skills required
Equipment and process validation
Sterile filling processes and equipment
Proficiency in Microsoft Office and job related computer applications required
Lean Six Sigma Methodology experience desired
Good Collaboration Skills
Ability to work as part of a team to determine priorities
Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
Demonstrated ability to drive the completion of tasks
Proven decision making capability with accountability and responsibility
3-5 years experience in a quality role, ideally in a pharmaceutical manufacturing environments. Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices Knowledge of cGMP and GDP preferred Report, standards, policy writing skills required Equipment and process validation Sterile filling processes and equipment Proficiency in Microsoft Office and job related computer applications required Lean Six Sigma Methodology experience desired Good Collaboration Skills Ability to work as part of a team to determine priorities Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance Demonstrated ability to drive the completion of tasks Proven decision making capability with accountability and responsibility Demonstrated ability to solve problems Bachelor Degree or higher preferred: ideally in a related Science discipline #LI- FP1
Employment Type
Full Time
