Quality Assurance Specialist

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Carlow
• State/Province Carlow
• 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.

A contract role for a Specialist, Quality Assurance

• Responsible for activities including some or all of thefollowing and any other tasks as required:
  
• Ensure data integrity principles: Attributable, Legible,Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records anddata in day-to-day business
  
• activities.
  
• Attend and successfully complete applicable cGMPtraining.
  
• Responds to Operational and business area's, drivescompliance with cGMP and corporate regulations.
  
• Drives cGMP/GDP compliance in the performance ofday-to-day business activities.
  
• Escalate any potential violation of cGMP and/or otherconcerns which may affect the safety, efficacy, quality, or purity of humanhealth products and aids resolution
  
• Liaise with the Quality/ Business Area Specialists/QP/QALead to resolve quality related queries where required
  
• Provides expertise C quality support for the introductionof new products onto site in relation to product release where required
  
• Ensure and promote that adequate processes and proceduresare in place and followed for all Quality activities.
  
• Report on and assist with monitoring the QualityManagement Systems. Generate reports for performance metrics and significantquality events C issues.
  
• Review and approval of all manufacturing batch/ materialdocumentation
  
• including electronic batch records, real time reports,master data using the site systems where required.
  
• Identify, influence and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
  

Requirements

Education:

• Bachelor's degree in Science, Engineering, Quality,Biotechnology, Pharmaceutical Sciences, Chemistry, Microbiology, or a relatedtechnical discipline.
  
• Relevant industry qualifications or certifications inQuality Management Systems, Compliance, Auditing, or Operational Excellence aredesirable.
  

Experience:

• Typically 3 to 5 years' experience in a regulatedpharmaceutical, biotechnology, medical device, or healthcare manufacturingenvironment.
  
• Demonstrated experience working within Quality Systemsand Compliance
  
• functions, including management of quality records,deviations, CAPAs, change controls, investigations, Complaints and documentmanagement systems.
  
• Knowledge of current GMP requirements and quality systemstandards applicable to pharmaceutical manufacturing.
  
• Experience collaborating with cross-functional teamsincluding Manufacturing, Engineering, Laboratory, Supply Chain, and TechnicalOperations.
  
• Knowledge of GMP, QMS, and regulatory requirements.
  
• Experience with Deviations, Complaints, Change Controls,APR/PQR, and Batch Record Review.
  
• Understanding of incoming material/product release andoutsourced manufacturing/packaging.
  
• Good knowledge of Good Documentation Practices (GDP).
  
• Strong communication and problem-solving skills.
  
• Able to work independently with moderate direction.
  
• Hybrid: 2-3 days onsite; day role, no shifts.
  

Skills and Competencies:

• Strong understanding of Quality Management Systems andGMP compliance requirements.
  
• Excellent analytical and problem-solving skills with theability to evaluate complex quality issues and identify sustainable solutions.
  
• Strong written and verbal communication skills, includingtechnical writing and report preparation.
  
• Ability to manage multiple priorities and deliver resultswithin agreed timelines.
  
• Effective stakeholder management skills with the abilityto influence across functions and levels of the organization.
  
• Strong attention to detail and a commitment tomaintaining data integrity and quality standards.
  
• Ability to interpret regulatory requirements andtranslate them into practical site procedures and processes.
  
• Proficiency in Microsoft Office applications andelectronic quality management systems.
  
• Demonstrated capability to drive continuous improvementand support a culture of quality and compliance.
  

Preferred Experience:

• Experience with site Quality Systems governance, metrics,compliance monitoring, and inspection readiness activities.