Quality Assurance Specialist

Full Job Description

Who we are?

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 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.

Job Title:Quality Assurance Specialist

JobDescription & Specific Objectives:

·         Worka 4-shift pattern role.

·         Technicalknowledge of sterile manufacturing processes

·         Performtimely reviews of batch documentation / investigations / reports highlightingand assist in the resolution of concerns commensurate with the risk.

·    Respondquickly to unplanned events, technical issues.

· Operationalexperience of quality systems in a dynamic manufacturing environment e.g. SAP,Trackwise, MES

·         Fullunderstanding of relevant quality and compliance regulations knowledge ofrequirements for cGMP, US and EU regulatory requirements

·         Conduct,report and display of Quality right first time, audit readiness metrics weeklyto ensure continuous audit readiness and cGMP compliance.

·         Supportthe spot check/walk-through process of the production lines.

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PositionResponsibilities:

·         ProvideQuality support to IPT production teams to ensure cGMP standards aremaintained.

·         Understandingof sterile manufacturing operations is preferred.

·        Abilityto learn and utilize computerized systems for daily performance of tasks.

·         Abilityto prioritize, manage multiple tasks, and meet deadlines.

·         Performtimely reviews on batch documentation (EBR’s ) / line clearances/ assist in theresolution of concerns commensurate with the risk. Liaise with other Departmentrepresentatives to promote improvements in GMP and Quality standards

·         Keepabreast of the latest developments from regulatory authorities in relation toQuality Compliance activities.

·         Complywith our current Manufacturing Division, Quality and EHS Management Systemrequirements, as relevant to commercial operations.

·         Fostera culture of continuous improvement by deploying client Six Sigma tools andsupport implementation of Model Area within operations from the start.

ReportingStructure: QualityAssurance IPT Manager

Qualifications& Experience - Knowledge and Skills Requirements:

Technical:

·         Sterilefilling processes and equipment and support services experience

·         LeanSix Sigma Methodology experience desired.

Education:

·         Degreequalification or equivalent (Science, Engineering, Technical)

·         Experiencein Sterile Manufacturing

General:

·         Goodorganizational skills and attention to detail

·         Requiresgood written, verbal and interpersonal communication skills and the ability toeffectively interact cross functionally.

·         Abilityto learn and utilize computerized systems for daily performance of tasks.

·         Stronginfluencing skills

·         Demonstrableanalytical and systematic problem-solving skills

People:

·         Focuson Customers and Patients

·         Collaborate

·         Actwith Candour and Courage

·         MakeRapid, Disciplined Decisions

·         DriveResults

·     DemonstrateEthics and Integrity