Sr Quality Systems and Compliance Specialist
Sr Quality Systems and Compliance 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 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.
The purpose of this role is to work within and support the Global Development Quality Assurance team at the Research & Development Division facility in Dunboyne. This role will primarily provide support for SAP Quality Master Data build Master Data approvals hypercare sustainment and ongoing updates. It will also support interface of SAP with IPI Product structure and MES BOMs and recipes. Other activities to support Quality Systems and QA Operations will be required as per start up schedule.
The QA Systems and Compliance Team with work closely with the Operations Engineering Validation Supply Chain and AR&D Functions to ensure compliance to Global and Regulatory Quality Management System requirements as they pertain to the Quality Manual Change Control Deviation Management Supplier Quality Management Quality Risk Management Audit Management and associated electronic systems.
Accountabilities include but are not limited to the following:
- Lead SAP master data build and data approval activities including hypercare sustainment materials build BOMs and Recipes.
- Participate daily on crossfunctional teams collaboratively and actively to address compliance issues and achieve project milestones.
- Support implementation and training for site Quality Systems and ensures activities are in Compliance with the current Quality Manual Requirements
- Support completion of Quality Systems activities e.g. related to Documentation Management Auditing Deviation Management Change Control Supplier Management and Quality Risk Management per schedule
- Support creation maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation.
- Create and maintain assigned SOPs.
- Provide QA review and approval of Change Controls Deviations/CAPAs SOPS and related documentation for compliance to GMP and site requirements at the startup facility.
- Support site QA Operations and QA Validation colleagues as required.
- Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture
- Support gathering of site metrics
- Ensure the escalation of compliance risks to management in a timely manner.
- Additional activities as assigned by the manager/supervisor
Requirements
- 23 years experience in an FDA / EMA regulated environment ideally in Quality Assurance Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
- Previous experience in QMS development and maintenance.
- Previous experience in QRM SQM Deviations and Change Control participating in investigations and problem solving.
- Strong attention to detail and precision in preparing and reviewing GMP documentation.
- Previous experience in quality management systems such as Veeva SAP DeltaV TrackWise PASX etc. or similar
- Strong written and verbal communication skills.
- Ability to think logically and be proactive under pressure.
- Ability to work as part of a team and on own initiative in a constructive manner.
- Knowledge of major Health Authority Guidelines and Regulations related to Biologics and/or Pharmaceuticals.
This role is a hybrid role.
2-3 years experience in an FDA / EMA regulated environment, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry. Previous experience in QMS development and maintenance. Previous experience in QRM, SQM, Deviations and Change Control, participating in investigations and problem solving. Strong attention to detail and precision in preparing and reviewing GMP documentation. Previous experience in quality management systems such as Veeva, SAP, Delta-V, TrackWise, PAS-X etc. or similar Strong written and verbal communication skills. Ability to think logically and be proactive under pressure. Ability to work as part of a team and on own initiative in a constructive manner. Knowledge of major Health Authority Guidelines and Regulations related to Biologics and/or Pharmaceuticals.
Education
2-3 years experience in an FDA / EMA regulated environment, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry. Previous experience in QMS development and maintenance. Previous experience in QRM, SQM, Deviations and Change Control, participating in investigations and problem solving. Strong attention to detail and precision in preparing and reviewing GMP documentation. Previous experience in quality management
Employment Type
Full Time
