QA Specialist

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.

Summary:

This role participates in maintaining site compliance of operations inclusive of but not limited to Manufacturing Quality Systems Quality Control Quality Assurance Facilities Maintenance Engineering Materials Handling and QA Validation in accordance with mandated regulatory requirements and site expectations.

Requirements

Essential Duties and Responsibilities include but are not limited to the following:

• Responsible for ensuring compliance with all aspects of Quality for the client site inclusive of manufacturing quality systems quality control validation facilities and materials management.
  
• Maintains regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
  
• Collaborates with Cross functional teams to resolve issues complete investigations and maintain compliance.
  
• Responsible for review and approval of the following types of documents:
  
• Failure investigations
  
• Corrective and preventative actions (CAPA)
  
• Standard operating procedures (SOP s)
  
• GxP documents
  
• Change control documents
  
• May lead & support root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver.
  
• Reviews procedures policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
  
• Monitoring and trending metrics associated with site quality systems.
  
• Actively participate in continuous improvement ideas initiation and implementation.
  
• May participate in internal regulatory and customer audits.
  
• May train personnel on quality system processes.
  
• Perform additional duties as requested.
  

Education and Experience:

• Assoc Specialist BS/BA in scientific discipline or related field or equivalent combination of education and experience
  
• Specialist BS/BA in scientific discipline or related field with 2 years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience
  
• Sr Specialist BS/BA in scientific discipline or related field with 5 years or MS 4 years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience