About PSC Biotech Who are we?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 PropositionEmployees 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.The purpose of this role
is to work within and support the Global Development Quality Assurance team
at the Research & Development Division facility in
Dunboyne. This role will primarily provide support for SAP Quality
Master Data build, Master Data approvals hypercare, sustainment, and ongoing
updates. It will also support interface of SAP with IPI Product structure and
MES BOMs and recipes. Other activities
to support Quality Systems and QA Operations will be required as per start up
schedule. The QA Systems and Compliance Team with work
closely with the Operations, Engineering, Validation, Supply Chain and AR&D
Functions to ensure compliance to Global and Regulatory Quality Management
System requirements as they pertain to the Quality Manual, Change Control, Deviation Management, Supplier Quality
Management, Quality Risk Management, Audit Management and associated electronic
systems.Accountabilities
include but are not limited to the following: Lead
SAP master data build and data approval activities including hypercare,
sustainment materials build, BOMs and Recipes.Participate daily on
cross-functional teams collaboratively and actively to address compliance
issues and achieve project milestones. Support implementation and training for site
Quality Systems and ensures activities are in Compliance with the current
Quality Manual RequirementsSupport completion of Quality
Systems activities e.g. related to Documentation Management,
Auditing, Deviation Management, Change Control, Supplier Management and
Quality Risk Management, per scheduleSupport creation, maintenance and continuous
improvement of Quality Management Systems (QMS) and associated
documentation. Create and
maintain assigned SOPs.Provide QA review and
approval of Change Controls, Deviations/CAPAs, SOPS and related
documentation for compliance to GMP and site requirements at the start-up
facility. Support site QA Operations and QA Validation
colleagues, as required.Work collaboratively to foster
strong relationships with management and colleagues and to drive a safe
and compliant culture Support gathering of site metricsEnsure the escalation of
compliance risks to management in a timely manner. Additional
activities as assigned by the manager/supervisorRequirements2-3 years’ experience in an FDA /
EMA regulated environment, ideally in Quality Assurance, Quality Control
or Technical Operations within the Biological and/or pharmaceutical
industry. Previous experience in QMS
development and maintenance. Previous experience in QRM, SQM,
Deviations and Change Control, participating in investigations and problem
solving.Strong attention to detail and
precision in preparing and reviewing GMP documentation. Previous experience in quality management systems such as Veeva, SAP,
Delta-V, TrackWise, PAS-X etc. or similarStrong written and verbal
communication skills. Ability to think logically and be
proactive under pressure. Ability to work as part of a team
and on own initiative in a constructive manner. Knowledge of major Health
Authority Guidelines and Regulations related to Biologics and/or
Pharmaceuticals. Bachelor’s
degree, or higher, in a Life Science disciplineThis role is a hybrid role.