Quality Assurance Specialist

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 cloudbased 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 likeminded 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 diversecultural work setting.

Employee Value Proposition

Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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

Job Description & Specific Objectives:

The Quality Assurance Specialist is required to:

Work a 4shift pattern role.

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 e.g. 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/walkthrough process of the production lines.

Involved in customer complaint investigation if required.

Support the annual product quality reviews if required.

Requirements

Position Responsibilities:

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

Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities.

Comply with our current Manufacturing Division Quality and EHS Management System requirements as relevant to commercial operations.

Foster a culture of continuous improvement by deploying client Six Sigma tools and support implementation of Model Area within operations from the start.

Reporting Structure: Quality Assurance IPT Manager

Qualifications & Experience Knowledge and Skills Requirements:

Technical:

Sterile filling processes and equipment and support services experience

Lean Six Sigma Methodology experience desired.

Education:

Degree qualification or equivalent (Science Engineering Technical)

Experience in Sterile Manufacturing

General:

Good organizational skills and attention to detail

Requires good written verbal and interpersonal communication skills and the ability to effectively interact cross functionally.

Ability to learn and utilize computerized systems for daily performance of tasks.

Strong influencing skills

Demonstrable analytical and systematic problemsolving skills

People:

Focus on Customers and Patients

Collaborate

Act with Candour and Courage

Make Rapid Disciplined Decisions

Drive Results

Demonstrate Ethics and Integrity

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