Quality Assurance Specialist – External Manufacturing (Remote)

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 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.

Overview:

• The Manufacturing & Supply Division of our company is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
  
• Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
  

• The Specialist – External Quality Vaccines acts as Product Quality Manager (PQM), responsible for ensuring that all our products managed by External Quality Assurance (EQA) are manufactured, packaged, analysed, released, stored, and distributed in accordance with our expectations and all applicable regulatory requirements. The role has primary batch release responsibility and ensures that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the External Partners (EP/ExP’s) manufacture and release of vaccine drug substance and drug products by means of risk-based quality oversight and on-site supervision, as appropriate.
  
• This is a 6 months Contract role.
  
  

Requirements

Role Functions:

• Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations
  
• Review and approve change controls
  
• Manage routine and complex deviations and complaints and assist in the coordination of significant investigations
  
• Conduct routine and solve complex analytical change requests and support process modification change controls
  
• Stability Program management, including review of stability reports, and Annual Product Review assembly
  
• Provide on-site guidance in the preparation of metrics, procedures, and guidelines
  
• Track and monitor operational and quality performance of the EP/ExP and can work with supplier to develop Corrective and preventive action (CAPA) plans
  
• Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration
  
• Responsible for shipment under quarantine
  
• Support routine process validation; review and approve validation reports/tech transfer
  
• Prepare pre-PAI assessments, support document requests for regulatory filings and post approval changes
  

Experience, Knowledge & Skills:

• Previous experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements preferred
  
• Solves complex problems; takes a new perspective using existing solutions
  
• Works independently with minimal guidance
  
• Explains difficult issues and works to build alignment around a complex situation
  
• Accountable for a medium project with minimal resource requirements, risk and/or complexity
  
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills
  
• Communicates easily in English both verbally and in writing
  
• Strong knowledge of External Manufacturing management, supply chain, and operations, preferably direct experience with managing external partners
  
  

Preferred Experience and Skills:

• Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines. Aseptic manufacturing experience
  
• Experience with qualification of manufacturing facilities/equipment (i.e. Process/Cleaning Validation, IQ/OQ/PQ)
  
• Competency in Analytical Method Validation/Verification/Transfer and Analytical Standards
  
• Quality Risk Management (QRM) Experience
  

Qualifications & Education:

• Bachelor's or Master's degree in a Science, Engineering, or related area of study.