Quality Investigations Specialist
Quality Investigations Specialist
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Job Description
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.
Overview:
- An amazing opportunity has arisen for a Support Operations Quality Notifications and Investigations Specialist to provide operational support for manufacturing operations of our Late Stage and Launch Pipeline products at our new state of the art single use biotechnology facility .
- Our facility is a premier state-of-the-art facility that enables and advances our best work. By integrating leading-edge technology with a dynamic activity-based workspace the facility will support seamless connection and collaboration within and across teams and functions. Our facility will provide Biologics Drug Substance manufacturing for Clinical Supply Registration & Commercial Launch.
- The facility is designed to be operated in a multi-product mode which requires flexibility to adjust as the pipeline of clinical and commercial biologics-based medicines demands change.
- Our facility serves as a magnetic force that attracts recognizes and integrates people of diverse backgrounds and perspectives. Employees will feel not only that they belong in the Team but that the facility belongs to and is shaped by them.
- This could be either a 6-month or an 12-month project depending on the final scope and requirements.
Reports to:Drug Substance Support Operations Associate Director
Requirements
Responsibilities:
- Author Quality Notifications: Take full ownership of drafting reviewing and finalizing Quality Notifications ensuring clarity accuracy and compliance with regulatory requirements. Initiate and maintain quality related metrics related to Quality Notifications ensuring effective communication and follow up of the same.
- Quality Metrics: Ensure that Quality notifications (including CAPAs Investigations and incidents) meet our metrics for raised on time and closed on time while maintaining a high standard of technical writing and compliance.
- Incident Reporting: Solely manage the authoring of incident reports documenting quality issues and ensuring timely submission for review and approval.
- Investigations Documentation: Lead the authoring of comprehensive investigation reports detailing findings root cause analyses and corrective actions.
- Approval Process Management: Navigate the approval process for all authored documents collaborating with cross-functional teams to ensure timely reviews and compliance with quality management systems.
- Quality Risk Assessments: Participate in Quality Risk Assessments as needed providing insights and documentation to support the evaluation of quality risks.
- Continuous Improvement: Contribute to a culture of continuous improvement by identifying opportunities for enhancing documentation processes and quality practices.
- Compliance Adherence: Ensure all authored documents meet the necessary compliance standards and are aligned with the Manufacturing Division Quality Management Systems (QMS).
- Training and Support: Provide guidance to team members on best practices for documentation and compliance fostering a culture of quality awareness
Skills & Education:
- Bachelor s degree in Biotechnology Chemistry Biology Pharmacy or Process engineering.
- 2 years experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components). Position level will scale with experience level of candidate.
- Strong technical writing capability and previous experience authoring reports and investigations in a GMP environment
- Competent in analysing complex situations and show practical problem-solving capabilities.
- Ability to work independently and within a cross-functional team.
Preferred Skills:
- Experience in leading and facilitating Root Cause Analysis and Quality Risk Assessment sessions
- Experience supporting Regulatory Inspections and Site Internal Audits
- Understanding of Upstream and Downstream Unit Operations for mAb manufacturing
Bachelor s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering. 2 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components). Position level will scale with experience level of candidate Experience in leading and facilitating Root Cause Analysis and Quality Risk Assessment sessions Experience supporting Regulatory Inspections and Site Internal Audits Understanding of Upstream and Downstream Unit Operations for mAb
Education
Bachelor s degree in Biotechnology, Chemistry, Biology, Pharmacy, or Process engineering. 2 years + experience in Biotech Industry (bulk manufacturing of pharmaceutical or biological components). Position level will scale with experience level of candidate Experience in leading and facilitating Root Cause Analysis and Quality Risk Assessment sessions Experience supporting Regulatory Inspections and Site Internal Audits Understanding of Upstream and Downstream Unit Operations for mAb
Employment Type
Full Time
