- Industry Pharma/Biotech/Clinical Research
- Work Experience 4-5 years
- City Galway
- 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:
- An exciting opportunity for a motivated and enthusiasticQC Analyst to join our amazing and fast-paced QC Department .You will help withcarrying out analytical testing on finished products, raw materials andstability using the correct procedures to comply with GMP, Health and Safety,SOP’s and environmental and regulatory requirements while ensuring we meet ourcustomer’s needs.
- This position is offered as a 12-month fixed-termcontract.
- 5-Days onsite
Requirements
Responsibilities:
- As a QC Analyst, you will play a vital role in ensuringthe quality and compliance of our materials and products through precise andtimely testing. Your key responsibilities will include:
- Conducting physical and chemical testing of rawmaterials, finished products (e.g., tablets, boluses, veterinary drenches),contract-manufactured goods, stability samples, validation lots, and cleaningvalidation samples using appropriate analytical techniques.
- Performing water analysis and environmental monitoringaccording to relevant procedures and schedules.
- Inspecting incoming materials such as foils, labels, bulkfinished goods, and injectables.
- Operating, calibrating, and maintaining laboratoryequipment in accordance with calibration and maintenance protocols.
- Adhering to all relevant Standard Operating Procedures(SOPs), pharmacopoeias, specifications, regulatory guidelines, and industrystandards.
- Maintaining laboratory logbooks, notebooks, andassociated documentation in compliance with Good Laboratory Practices (GLP).
- Supporting the QC testing schedule to help achieve acustomer service level of >95%.
- Ensuring all QC records are accurately maintained andproperly filed.
- Liaising with team leaders, supervisors, and productionstaff to ensure timely reporting and resolution of results.
- Providing prompt feedback and escalating anydiscrepancies, deviations, or non-conformances as required.
- Coordinating the dispatch of samples for externalanalysis when necessary.
- Managing relationships with external suppliers/vendorsfor QC-related consumables.
- Participating in internal laboratory rota tasks andcontributing to general housekeeping and hygiene within the lab.
- Upholding laboratory safety standards and identifyingareas for improvement.
- Performing additional responsibilities as assigned by theQC Team Leader, Supervisor, or Manager.
Education & Experience:
- Bachelor’s degree (Level 8 or equivalent) in achemistry-based discipline.
- Experience working in a pharmaceutical Quality Controllaboratory operating under cGLP standards.
- Familiarity with regulatory guidelines including EU GMPand US FDA standards (experience preferred but not essential).
- Strong knowledge of analytical techniques including HPLC,IR, UV, dissolution, and physical testing.
- Ability to build effective working relationships andcollaborate within cross-functional teams.
- Excellent verbal and written communication skills.
- Maintains high ethical standards; escalates issuesappropriately when necessary.
- Demonstrates flexibility and a willingness to learn anddevelop technical expertise.
- Highly organised, methodical, and systematic in approachto work.
- Positive, proactive, and energised by responsibility andaccountability.
- Able to prioritise tasks effectively, distinguishingbetween urgent and non-urgent matters.
- Takes initiative, seeks clarification when needed, andaccepts direction constructively.
- Contributes to a supportive, team-oriented environment.
- Strong computer literacy, particularly in MicrosoftOffice (Excel, Word, Outlook, etc.).