About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm founded in ****, 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.
Overview:
The Quality Assurance Specialist within Our Company is required to
Technical knowledge of sterile manufacturing processes
Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk
Respond quickly to unplanned events, technical issues
Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES
Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements
Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
Support the spot check/walk-through process of the production lines
Involved in customer complaint investigation if required
Re
s
ponsibilities:
Provide Quality support to IPT production teams to ensure cGMP standards are maintained.
Understanding of sterile manufacturing operations is preferred.
Ability to learn and utilize computerized systems for daily performance of tasks.
Ability to prioritize, manage multiple tasks, and meet deadlines.
Perform timely reviews on batch documentation ( EBR's ) / line clearances/ assist in the resolution of concerns commensurate with the risk.
Liaise with other Department representatives to promote improvements in GMP and Quality standards
Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.
Reporting Structure:
Reports to Quality Manager
Qualifications & Experience - Knowledge & Skills Requirements:
Skills and Knowledge:
Typical Minimum Education
Bachelor's Degree or higher preferred in a Science discipline
Typical Minimum Experience:
1-2 years experience in a Quality Role at pharmaceutical manufacturing facility preferably aseptic manufacturing
Experience in SAP, MES, Trackwise desirable
Technical:
Working knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
Knowledge of cGMP and GDP essential Report, standards, policy writing skills required
Competent in the use of MES and SAP
Shift Pattern:
This is a shift position – 4 cycle 12 hours per shift e.g
Week 1- long week: Monday – Tuesday Days, Friday, Sat, Sun nights
Week 2- short week: Wed and Thurs Days,
Week 3:Long week: Monday – Tuesday nights, Friday, Sat and Sun Days
Week 4: short week: Wed and Thu Nights