Operational Quality Specialist

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 points 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 to 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 through Learning & Development in-house training mentorship with constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client's expectations regarding quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

• 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 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 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 the development of Quality Systems as an active member across cross-functional teams, to deliver process improvement. The Quality Specialist will model the 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 Quality Management System (QMS) requirements, including ownership as required.
  

Primary Responsibilities:

• Provides to the site expertise in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/Investigations/ Change Management; environment monitoring programs; sterility assurance/low bioburden manufacturing; etc.
  
• Uses knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks.
  
• Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality.
  
• Understands and applies regulatory/compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
  
• Required to be proficient in Quality approval and oversight for Commissioning and Qualification activities (IQ/OQ/PQ).
  
• Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
  
• Makes decisions within guidelines and policies which impact Product Quality, Projects and 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.
  
• 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.
  
• Participate in GMP Walkthroughs.
  
• 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.
  

Shift Pattern: The role is a shift, full-time onsite role providing quality oversight to Operational. This role is integrated into the production area. The shift is 5/2, week 1 is M/T/F/S/S all 11-hour days. Week 2 is W/T 11.30 hr days.

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