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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.

Job Description:
This position within the QA department will provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site and in meeting the client s priorities of: Compliance, Supply, Strategy and Profit Plan.

The team working style is one of collaboration, coaching and facilitation to ensure the success of the site. The Associate Quality Specialist is accountable for the Quality Systems within the site.

This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment.

The Quality Specialist will have proven capability in development of Quality Systems as an active member, across cross functional teams, to deliver process improvement. The Quality Specialist will model the client s Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organisation.

The Quality Specialist will participate and comply with the client s Quality Management System (QMS) requirements, including ownership.

Requirements

Primary activities/responsibilities:

• Provides to the site knowledge and experience in Quality Systems.
  
• Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement, and execute tasks.
  
• Provides compliance contribution to project teams and leads small projects.
  
• Coaches and guides colleagues within the site.
  
• Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
  
• Responds to non-standard requests from customer needs.
  
• Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
  
• Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed.
  
• Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.
  
• Participation in and leading internal inspections
  
• Participate in GMP Walkthroughs.
  
• Manage supplier agreements and supply maps
  
• Deviation Management & Change Control approval.
  
• Ensures supply of high-quality product through the implementation and oversight of the Quality Management System for the site.
  
• Champion the highest Quality and Compliance standards for the site.
  
• Ensure highest safety standards.
  
• Additional activities as requested by QA Lead
  

Required:

• Degree or 3rd level qualification (Science, Quality).
  
• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation
  
• 5 years experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function
  
• Quality Assurance SME knowledge, from both operational and educational experience, is required
  
• Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site
  
• Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance
  
• Demonstrated ability to work and succeed within teams as well as leading small project teams.
  
• Demonstrated ability to drive the completion of tasks.
  
• Proven track record of providing independent Quality support to the site.
  
• Advanced PC skills such as Excel, Word, PowerPoint.
  
• Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
  
• Proven decision-making capability with full accountability and responsibility.
  
• Energetic with proactive & positive attitude.
  
• Demonstrated coaching skills.
  
• Demonstrated ability to solve problems.
  

Desired:

• Desirable evidence of Continuous Professional Development.
  

#LI-SO1

Primary activities/responsibilities: Provides to the site knowledge and experience in Quality Systems. Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement, and execute tasks. Provides compliance contribution to project teams and leads small projects. Coaches and guides colleagues within the site. Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes. Responds to non-standard requests from customer needs. Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines. Supports Corporate Quality to ensure actions related to Quality Systems at the site are executed. Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable. Participation in and leading internal inspections Participate in GMP Walkthroughs. Manage supplier agreements and supply maps Deviation Management & Change Control approval. Ensures supply of high-quality product through the implementation and oversight of the Quality Management System for the site. Champion the highest Quality and Compliance standards for the site. Ensure highest safety standards. Additional activities as requested by QA Lead Required: Degree or 3rd level qualification (Science, Quality). Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation 5 years experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function Quality Assurance SME knowledge, from both operational and educational experience, is required Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance Demonstrated ability to work and succeed within teams as well as leading small project teams. Demonstrated ability to drive the completion of tasks. Proven track record of providing independent Quality support to the site. Advanced PC skills such as Excel, Word, PowerPoint. Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels. Proven decision-making capability with full accountability and responsibility. Energetic with proactive & positive attitude. Demonstrated coaching skills. Demonstrated ability to solve problems. Desired: Desirable evidence of Continuous Professional Development. #LI-SO1