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 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.
Essential Job Functions:
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Act as a business process manager for applicable quality systems.
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Assess GMP and regulatory compliance risk areas and develop and implement risk mitigation measures in conjunction with the accountable parties.
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Work with key stakeholders to identify and implement system improvements,
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Analyse performance through metrics and trending,
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Troubleshoot issues and support the business with queries,
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Benchmark leading practices & identify opportunities to enhance systems,
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Liaise with global colleagues to share learnings to ensure consistency across the network and alignment with global processes.
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Provide QA review and/or approval for Supplier Management and other Quality System activities impacting GxP operations, including (but not limited to):
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Deviations
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Changes
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Specifications
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Technical / Quality Agreements
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Provide additional support to Quality Systems and Compliance team:
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Support audit and inspection activities for site, including preparation, participation, and follow up actions.
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Lead activities associated with the site quality management review process.
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Other duties as assigned.
Qualifications & Experience:
Education:
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Bachelor’s degree in Pharmaceutical Sciences, Process Engineering or related discipline.
Experience:
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10–15+ years experience within GMP-regulated pharmaceutical or biotechnology environments
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3-5 years in leadership roles, with experience in people management and a proven ability to influence cross-functional teams and stakeholders.
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Significant hands-on experience supporting regulatory inspections.
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Knowledge of EU GDP Guidelines and regional regulatory requirements.
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Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk
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VIVA Vault - QMS
Skills:
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Excellent communication and influencing skills across all organizational levels.
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Planning and organising skills.
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Detail-oriented, analytical thinker.
