QC NPI Analyst

PSC Biotech Corporation; Galway; Hybrid; EUR 42,000 - 62,000; Full time

Job summary

PSC Biotech Corporation in Ireland is seeking a QC Analyst to join the Quality Control New Product Introduction function. You will support analytical testing of raw materials, APIs and excipients, ensuring GMP compliance and timely delivery of methods and data.

The role requires a bachelor’s degree in a chemistry-based discipline, 3+ years in a pharma cGMP environment, and strong documentation and collaboration skills to work with R&D, QA and regulatory teams.

Qualifications

• Bachelor’s degree in chemistry-based discipline.
• 3+ years of experience in an R&D/QC analytical role in pharma.
• Experience in a cGMP/cGLP environment and regulatory familiarity.
• Experience with analytical method transfers and validations.

Responsibilities

• Perform analytical testing of Raw Materials, API and Excipients using approved procedures.
• Carry out testing in GMP-compliant laboratory with proper documentation and safety practices.
• Plan, prioritise and execute analytical activities to meet R&D and NPI timelines.
• Prepare ECPs and support Vendor Approval processes.
• Maintain GLP standards and ensure accurate data recording and filing.
• Communicate results to R&D, QA, Regulatory and Purchasing teams.

Skills

Analytical chemistry

Laboratory testing

Documentation

Team collaboration

Education

Bachelor's degree in chemistry-based discipline

Tools

HPLC

GC

Analytical method transfer

Method validation

Job description

Loughrea, Ireland | Posted on 05/29/2026

• Industry Pharma/Biotech/Clinical Research
• City Loughrea
• State/Province Galway
• 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.

Overview:

• This is an opportunity to be part of a dynamic teamwithin the Quality Control New Product Introduction function. We are lookingfor individuals who will support and drive client’s Pharma vision to be the most valued global provider of high quality, competitively pricedpharmaceutical products and to provide excellent services and support to ourcustomers.
  
• In this role you will report into the QC Manager.
  

Requirements

Responsibilities:

• Displays the capability to learn and understand methodsshowing competency in the following technical areas: HPLC, GC, IR, UV,dissolution & Physical testing.
  
• To carry out analytical testing on Raw Materials, API andExcipients using the correct Analytical procedures (e.g. API suppliersAnalytical methods or Pharmacopeia Monograph methods as required) whilecomplying with GMP, SOP’s Health, Safety and Environmental and Regulatoryrequirements with minimum Human error as per relevant timelines.
  
• Plan, prioritise and execute analytical activities inalignment with Team Leader, Purchasing, R&D and Product Launch in order tomeet R&D and Launch project timelines and agreed New Product Introductionpriorities.
  
• Adapt testing priorities in response to evolving R&D,Product Launch and Purchasing requirements, in agreement with the QC Manager,to support successful product development and launch.
  
• Preparation of ECP’s and support Vendor Approval.
  
• Performing Analytical Method Transfers related to any RawMaterials & Packing materials (as applicable) with Protocol / Reportpreparation.
  
• Performing Analytical Method Validation / Verificationsrelated to any Raw Materials & Packing materials (as applicable) withProtocol / Report preparation.
  
• Characterization of APIs and Reference Products for theproposed Medical/Veterinary Raw Materials Products (as required).
  
• Approval of Raw Materials and the issue of associateddocuments and labels (as applicable).
  
• Responsible for sending & following up samples whereExternal testing is required and receiving, filing the External testing resultsfollowed by circulating to relevant stakeholders(as applicable).
  
• Responses to queries from Third parties / RegulatoryAuthorities as per agreed timelines.
  
• Writing Technical Reports.
  
• Ensuring timely availability and liaising with externalsuppliers/vendors (if required) for Reagents/Chemicals/Analytical test Methods& Columns required in routine analysis to avoid delays in testing.
  
• Ensure the log books/experiment registers / Laboratorynotebooks are completed contemporaneously.
  
• Reviewing Analytical raw data associated Raw Materialtesting, Analytical Method Validation/ Verification etc. (if required).
  
• Generation of data to support existing ECPs changes incase of DMF/Supplier technical data update(as required).
  
• Calibration and maintenance of laboratory equipment asper calibration procedures (as required).
  
• Making the NPI process more efficient (lean management)where appropriate suggestions shall be made for Continuous improvement.
  
• Communicating with other departments (R&D/QC/ProductLaunch/Quality Assurance/Regulatory Affairs/Purchasing) and following up withthem in relation to any queries in timely manner.
  
• Filing, reporting & organisation of raw datagenerated during analysis.
  
• To bring to the notice of the Supervisor QC NPI if anydiscrepancies, deviations or non-conformances in testing or with work practicewhile complying to cGMP & Data Integrity principles.
  
• Perform detailed root cause investigations into OOS /OOT/Laboratory Incidents that occurs in any analysis performed.
  
• Represent company in times of Internal/External audits(either from Customer or regulatory authorities).
  
• Maintain the QC Laboratory up to GLP standards and adhereto any agreed internal laboratory rota tasks.
  
• To maintain good housekeeping and hygiene within thelaboratory and adherence to laboratory safety measures at all times.
  
• Any other duties as assigned by the Team Leader orManager.
  
• If decided appropriate it may be decided to amend/updateany of the above responsibilities.
  
• Working experience in a GMP Laboratory or R&D(Formulation) or Raw material testing is a distinct advantage.
  
• Proficiency with Microsoft Office suite.
  
• Excellent communication and interpersonal skills withgood collaborative skills.
  
• An ability to work independently and as a member of ateam in a dynamic, fast-paced environment.
  
• Excellent written and communication skills.
  
• Ability to build relationships and collaborate withothers.
  
• Maintains the highest standards of ethical behaviour.Escalates issues appropriately.
  
• Flexible and shows willingness to learn to developtechnical skills.
  
• Takes a methodical, systematic, and structured approachto organising work.
  
• Positive and proactive person who is energized by havinggreat responsibility.
  

Qualifications:

• 3rd level qualification – bachelor’s degree in achemistry-based discipline.
  
• Experience in Analytical MethodTransfer, Technical Transfer,AnalyticalMethod Validation/Verification & Raw MaterialTesting
  
• 3+ years’ experience in a R&D/QC Analyst role.
  
• Experience working within a pharmaceutical cGLP/cGMPEnvironment; with knowledge of EU GMP and US FDA Guidelines.
  

Physical Demands:

Health & Safety requirements (eg. Manual Handling Training)

• To take reasonable care for their own safety, health andwelfare at work and that of any other person that may be effected by their actsor omissions while at work.
  
• To cooperate with client or any of its representativesthat will enable the company to comply with the relevant health and safetystatutory provisions.
  
• Adheres to safety regulations by ensuring correct usageof PPE in the lab area.
  
• Reports to the Supervisor or health and safetyrepresentative without unreasonable delay any defects in plant, equipment,place of work, system of work which might endanger safety, health or welfare ofthemselves or any employee, contractor or visitor to the company.
  
• Keeps work area safe, clean and tidy.
  
• Not to intentionally or reckless interfere with or misuseany appliance, protective clothing, convenience, equipment or other means or thing provided.
  
• Duties for this position will predominantly be Laboratorybased.