QA Associate

3 weeks ago

Dublin, Dublin City, Ireland PSC Biotech Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 1-3 years
  • City Dublin
  • State/Province Dublin
  • Country Ireland
Job Description

About PSC Biotech

Who we are?

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 Proposition

Employees 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.

Job Title: QA Associate

Job Overview:

The QA Associate will report to the QA Manager, playing apivotal role in the site's Quality Assurance team. As the Quality point ofcontact for manufacturing and inspection operations, the QA Associate willcontribute to continuous improvement initiatives by undertaking additionalresponsibilities beyond routine QA duties.

This 24/7 shift role demands a 12-hour shift pattern (4 on,4 off) to support manufacturing operations.

Requirements

Key Qualifications & Experience:

· Exceptional written and verbal communicationskills.

· Proven experience collaborating with dynamiccross-functional teams and strong decision-making abilities.

· Robust organizational skills, with a commitmentto seeing assignments through to completion.

· Demonstrated problem-solving abilities,particularly in supporting non-conformance/deviation investigations.

· Experience in inspecting vials and syringes andengaging in aseptic operations.

· Familiarity with applicable Regulatoryrequirements and proficiency in evaluating compliance issues.

Key Responsibilities:

· Ensure adherence to safety standards and SOPs inall activities.

· Review and approve production batch records andassociated documentation for Qualified Person disposition activities.

· Provide real-time quality oversight and supportfor production unit operations, extending to formulation, vial and syringe FillFinish activities, including media fills and assessment of asepticinterventions.

· Conduct inspections of vials and syringes aspart of AQLs, annual reserve inspections, and support complaint investigations.

· Offer Quality Assurance support for on-the-floorinvestigations and deviations.

· Review and approve deviations for closure,ensuring compliance with appropriate documentation.

· Participate in customer complaintinvestigations.

· Conduct routine Quality Assurance walks on theproduction floor.

· Review and issue logbooks, ensuring compliancewith procedures.

· Provide training and guidance to staff foreffective performance.

· Review and approve cGMP records, ensuringcompliance with appropriate documentation.

· Support continuous improvement and OperationalExcellence initiatives.

· Undertake other tasks/projects as assigned bythe manager.

Basic Qualifications & Experience:

· University degree in an Engineering orScience-related discipline (preferred).

· Over 1 to 3 years of relevant experience in thepharmaceutical or biotechnology industry or an equivalent combination ofexperience and educational background.

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