QA Specialist (NPI)

Overview

Ensures NPI quality compliance, reviews documentation, supports cross‑functional teams.

Key Responsibilities

• documentation review
• change control
• equipment qualification
• supplier management
• batch records
• project delivery

Tasks

-Collaborate with stakeholders such as Quality Control (QC), Manufacturing Science & Technology (MS&T), Engineering, and Warehouse to develop, review, and maintain documentation and quality records throughout the product lifecycle (e.g., method validations, facility upgrades, qualification protocols, calibration records). -Review and approve change controls, corrective and preventive actions (CAPAs), deviations including investigation protocols, root cause analysis and final investigation reports. -Review and approve Good Manufacturing Practice (GMP) documentation and data to ensure accuracy, completeness, and compliance. -Review and approval of Equipment qualification including IOQ and PQ, process validation, development studies, hold time studies etc. -Review and approve batch records. -Oversee quality aspects of material and supplier management, including preparation of material qualification packages, supplier audit assessments, and maintenance of the supplier management system. -Provide quality assurance support across functional and cross-functional forums. -Ensure the highest Quality, Compliance and Safety standards. -Contribute to the identification, development, and execution of continuous improvement initiatives and action plans in collaboration with cross-functional teams. -Partner cross-functionally to support timely delivery of project milestones.

Requirements

• bachelor's
• qa experience
• risk assessment
• single‑use
• gmp
• cgmp

What You Bring

A QA NPI Specialist is required for a biopharmaceutical company is North Dublin. The incumbent will ensure that the New Product Introduction objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, as well as meeting Health Agency regulations and all other applicable governing regulations. -Bachelor’s degree (or higher) in Chemistry, Biology, Microbiology, Engineering or Supply Chain in a relevant discipline. -5 to 8 years’ experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations. -Familiarity and participation in risk assessment processes. -Proven track record in delivering excellence. -Strong knowledge of qualification and implementation of Single Use technologies and raw materials and supplier qualifications for use in a GMP environment. -Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.

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About Tandem Project Management Ltd.

-Founded in the heart of Ireland, Tandem Project Management Ltd. has grown into a key player in delivering high-quality project management solutions across multiple industries. -The company has a proven track record of success in managing large-scale, complex projects, consistently delivering on time and within budget. -Specialising in sectors like industrial, commercial, residential, and transport, Tandem brings expertise to projects ranging from urban developments to large infrastructure projects. -Tandem Project Management Ltd. thrives in challenging environments, with a deep understanding of project intricacies and client requirements. -Their approach is rooted in collaboration, working closely with clients and stakeholders to ensure projects meet all expectations and deliver lasting value. -The firm is known for its hands-on, proactive management style, providing solutions at every stage of the project lifecycle. -With a focus on maintaining robust relationships, Tandem is dedicated to fostering trust and long-term partnerships with clients.

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