Quality Assurance Specialist -NPI

Job title:

Quality Assurance Specialist -NPI

Company

PSC Biotech

Job description

About PSC BiotechWho 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 PropositionEmployees 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:An amazing opportunity for a Quality Assurance Specialist to join our quality team. In this role, you will play a vital role in supporting the introduction of new products and Quality oversite of executed validation completed.As the QA Specialist for Validation and New Product Introduction (NPI), you will be an essential member of our esteemed Technical Transfer/Validation Team. This team holds responsibility for managing the development and manufacture of vaccines and biological products. Alongside your day-to-day QA activities, your main focuses will be reviewing and approving all Validation documents relating to a sterile facility including cleaning validation ensuring to support corporate compliance and regulatory expectations for manufacturing.You will report to the Associate Director of Quality and collaborate closely with cross-functional teams on-site, particularly Technical Engineering. Your key objective will be to ensure that manufacturing, technical, and regulatory requirements are met.RequirementsResponsibilities:

• Provide quality oversight and direction for the introduction of new products.

• 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.

• 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, such as, QC Test Specifications, BOMs, and MES documentation.

• Support deviation close out in a timely manner.

• 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.

Skills & Education Required:

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

• 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.

Reporting To: Associate Director of Quality#LI-AP1

Expected salary

Location

Carlow

Job date

Thu, 09 Jan 2025 23:39:06 GMT

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