QA Operations Specialist

PSC Biotech Corporation; Dunboyne; On-site; EUR 55,000 - 75,000; Full time

Job summary

PSC Biotech Corporation invites applications for a QA Operations Specialist to support clinical and commercial operations at a single-use, multi-product biotech facility in Ireland. You will drive quality systems, compliance, and continuous improvement across site teams.

Requirements include a Science or Pharmacy degree and a minimum of 3 years’ experience in biotechnology/pharmaceutical industries, plus experience with deviation management and Change Controls, and strong knowledge of cGMPs.

Qualifications

• Degree or post-graduate qualification in Science, Pharmacy or equivalent.
• Minimum 3 years’ experience in the biotechnology and/or pharmaceutical industry.
• Previous Experience with deviation management/Change controls
• Knowledge of cGMP regulations both domestic and international.

Responsibilities

• Provide QA oversight to the clinical and commercial operations at the facility including quality control, supply chain, engineering and manufacturing support, and regulatory approvals.
• Responsible for supporting execution of an effective Quality system and accountable for quality oversight of quality management systems (CAPAs, Change Controls, Deviations, Batch Documentation Review).
• Liaises with internal partners to support daily operations.
• Coordinate with peer Quality groups to ensure on-time disposition of commercial Drug Substance.
• Ensures clear communication on issues and timely escalation as applicable.
• Helps maintain site practices and procedures related to clinical and commercial operations.
• Adheres to domestic and international GMP regulations and company policies.
• Champion site metrics to ensure targets are achieved and counter measures are in place when applicable.

Skills

Deviation management

Change controls

Batch Record Review

cGMP knowledge

Problem solving

Decision making

Teamwork

Pressure handling

Education

Science or Pharmacy degree

Post-graduate qualification

Job description

• Industry Pharma/Biotech/Clinical Research
• Work Experience 4-5 years
• City Dunboyne
• State/Province Meath
• 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 amazing opportunity has arisen for a QA OperationsSpecialist. This role will be responsible for supporting the clinical andcommercials operational activities, at single use multi-product biotechfacility. You willworks across siteteams to resolve issues and drive quality, EHS, learning, and continuousimprovement, while ensuring compliance with cGMP and corporate regulations.

Requirements

What you will do:

Bring energy, knowledge, innovation and leadership tocarry out the following:

• Provide QA oversight to the clinical and commercialoperations at the facility including quality control, supply chain, engineeringand manufacturing and support process technical transfers, analytical technicaltransfers, drug substance disposition and regulatory approvals.
  
• Responsible for supporting execution of an effectiveQuality system and accountable for quality oversight of quality managementsystems (CAPAs, Change Controls, Deviations Batch Documentation Review).
  
• Liaises with internal partners (e.g. ManufacturingOperations, MS&T, Engineering functions etc) in support of dailyoperations.
  
• Coordinate with peer Quality groups to ensure on-timedisposition of commercial Drug Substance.
  
• Ensures clear communication on issues and timelyescalation as applicable.
  
• Helps maintain site practices and procedures related toclinical and commercial operations.
  
• Responsibility for adhering to domestic and internationalGMP regulations, cGMP’s, company policies, leadership behaviors, andperformance and budget management.
  
• Champion site metrics to ensure targets are achieved, metand counter measures in place when applicable.
  
• Representing Quality on multidisciplinary teams.
  
• Executing company policies.
  
• Ensures new/revised quality system requirements aredeployed to the Site.
  
• Ability to work on his/her own initiative in addition toworking as part of a team
  
• Possess strong problem solving and trouble shootingskills
  

What skills you will need:

In order to excel in this role, you will more thanlikely have:

• Degree or post-graduate qualification in Science,Pharmacy or equivalent.
  
• Minimum 3 years’ experience in the biotechnology and/orpharmaceutical industry.
  
• Previous Experience with deviation management/Changecontrols
• Previous Experience in Batch Record Review is preferable
• Knowledge of cGMP regulations both domestic andinternational.
• Proven decision-making capability with fullaccountability and responsibility.
• Ability to think logically and be proactive underpressure.
• Ability to work as part of a team and on own initiativein a constructive manner.