Quality Systems Compliance Specialist
Quality Systems 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.
Overview:
The Quality Systems Compliance Specialist is responsible for maintaining and continuous improvement of our Quality Management System throughout their knowledge and areas of expertise. Ensure that objectives are effectively achieved consistent with our requirements to ensure compliance safety and reliable supply to our customers.
Requirements
Responsibilities:
- Provide quality support to the project and site including training and guidance on the interpretation and implementation of our Guidelines / Policies and regulatory requirements.
- The main areas of expertise are but not limited to specific tasks and roles such as: deviation management change control management quality systems management document / SOP management data integrity management GMP training & knowledge management.
- Ensure the health & wellbeing of the Quality Management system at the site to ensure timely actions are taken to meet compliance & production needs.
- Serve as support for metrics management for site deviation management and change control systems.
- Support the review and approval of site deviation and investigations reports.
- Support maintenance of the site master file and site manufacturing license and variations as required.
- Ensure root causes have been identified and corrective action implemented and can demonstrate basic knowledge of six sigma LEAN and root cause analysis tools used for identifying and correcting deviations.
- Day to day management of Deviation CAPA and Change Control QRM metrics.
- Support the oversight of the quarterly deviation trending process (by cross functional area owners) on a routine basis and responsible for the completion of annual trending at Site.
- Liaise directly with crossfunctional departments to ensure that change control and deviation management system requirements are met.
- Support Regulatory and Compliance Inspections at the site as required.
- Support for management of recalls as required.
- Comply with our Global and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of daytoday activities and all applicable job functions.
- Build a Quality culture that delivers unconstrained supply Right First Time to our patients.
- Support Quality Risk Management process
Skills Required:
- Over 4 years experience in Quality Control Quality Assurance or Pharmaceutical Vaccine or Biological Operations or Technical Operations.
- Motivated to be an inspiring member of a high performing team.
- Excellent interpersonal skills: communication decision making people influencing skills.
- Ability to interact with multiple stakeholders.
- Desire to continuously learn improve and develop.
- Excellent knowledge of relevant Quality and Compliance Guidelines (cGMP Auditing Quality Management Systems Quality Agreements Regulatory Affairs Training) and respective regulations.
- Experience with new product introductions and/or process qualification/technology transfer.
- Bachelor s degree (or higher) in Chemistry Biology Microbiology Automation Engineering or equivalent.
#LIEL1
Over 4 years experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations or Technical Operations. Motivated to be an inspiring member of a high performing team. Excellent interpersonal skills: communication, decision making, people influencing skills. Ability to interact with multiple stakeholders. Desire to continuously learn, improve and develop. Excellent knowledge of relevant Quality and Compliance Guidelines (cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, Training) and respective regulations.
Education
Over 4 years experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations or Technical Operations. Motivated to be an inspiring member of a high performing team. Excellent interpersonal skills: communication, decision making, people influencing skills. Ability to interact with multiple stakeholders. Desire to continuously learn, improve and develop. Excellent knowledge of relevant Quality and Compliance Guidelines (cGMP, Auditing, Quality Management
Employment Type
Full Time
