Utilities Supervisor
Posted on :
02-06-2024
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1 Vacancy
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Job Description
Req ID : 2497452
About PSC Biotech
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.
Reporting to the Associate Director of Quality Assurance within Global Development Quality (GDQ), the Quality Assurance role will support the wider Quality Assurance team at the site.
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.
Requirements
What you will do:
Bring energy, knowledge, innovation and leadership to carry out the following:
- Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes.
- Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones.
- Support implementation and training for site Quality Systems and site GMP readiness activities.
- Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation.
- Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility.
- Support other QA 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 risks to management in a timely manner.
What skills you will need:
In order to excel in this role, you will more than likely have:
- 5 years experience in an FDA / EMA regulated environment, ideally in Quality Assurance, Quality Control, Operations or Technical Operations within the Biological and/or pharmaceutical industry.
- Previous experience in SAP Master Data build and maintenance
- QMS development and maintenance.
- Previous experience in 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.
Desirable:
- Experience in direct interactions with regulatory agencies during site inspection.
#LI-AM1
What you will do: Bring energy, knowledge, innovation and leadership to carry out the following: Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes. Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones. Support implementation and training for site Quality Systems and site GMP readiness activities. Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility. Support other QA 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 risks to management in a timely manner. What skills you will need: In order to excel in this role, you will more than likely have: 5 years experience in an FDA / EMA regulated environment, ideally in Quality Assurance, Quality Control, Operations or Technical Operations within the Biological and/or pharmaceutical industry. Previous experience in SAP Master Data build and maintenance QMS development and maintenance. Previous experience in 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. Desirable: Experience in direct interactions with regulatory agencies during site inspection.
Employment Type
Full Time
Department / Functional Area
Key Skills
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