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 QualitySpecialist role:• Participate asfunctional expert in the cross functional team that manages production right firsttime at site.• Review and approvebatch, cleaning and testing documentation.• Ensure that allLaboratory Out of Specification (OOS) and process deviations are documented, assessedand associated CAPA identified.• Provide support todeviation investigations and process performance monitoring.Perform trending ondeviations raised as required to identify improvement initiatives.• Provide detailedknowledge of quality systems in place and ensure that root cause is identified andcorrective actions as appropriate are completed.• Provide guidance onquality requirements to maintain validation status, including participation inprocess/product Risk Assessments.• Provide feedback onre -occurring issues ensuring continuous improvement to systems/processes.• Ensure changescontrols raised are documented, assessed and completed.• Prepare AnnualProcess and System Reviews.• Act as lead/teamauditor to support the internal GMP walkdown and scheduled audits.• Participate in thegeneration and communication of quality metrics.• Creation, review andapproval of quality procedures as required.
RequirementsWhat skills youwill need:In order to excel inthis role, you will more than likely have:• Degree orpost -graduate qualification in Science, Pharmacy or equivalent.• Knowledge of QualityIT systems desirable (e.g. SAP, Trackwise).• Knowledge anddemonstrated expertise in Lean / Continuous Improvement.• Experience andknowledge of GMP Requirements for Electronic /paper freeoperations.• Experience in Highpotency manufacturing desirable.• Communications:Excellent written and oral communication skills. Organizes and delivers informationappropriately.• Team Work: Interactswith people effectively. Able and willing to share and receive information.• Decision Making:Uses sound judgement to make good decisions based on information gatheredand analysed.• Adaptability: Adaptsto changing work environments, work priorities, organizational needs and diversepeople.• Work Standard: Setsand maintains high performance standards. Pays close attention to detail,accuracy and completeness.• Motivation: Displaysenergy and enthusiasm. Maintains high level of productivity and self direction.