QA Specialist Clinical Trial Supply / IMP Compliance

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 successful candidate will be part of a collaborative and high-performing team comprising Quality Specialists and Qualified Persons (QPs) working closely with partner teams in the UK Switzerland and the US to ensure the integrity of the Clinical Supply Chain.

Requirements

Key Responsibilities:

• Audit and review batch documentation to ensure compliance with SOPs cGMPs and applicable regulations.
  
• Review and approve production and analytical documentation related to drug substance drug product and packaged finished goods supporting QP certification.
  
• Maintain effective communication and collaboration with cross-functional teams to foster strong working relationships and a clear understanding of responsibilities.
  
• Resolve comments and issues arising during audits and documentation review by leveraging internal networks.
  
• Manage product recalls and stock recoveries in accordance with procedures.
  
• Identify compliance gaps and recommend continuous improvement initiatives.
  
• Author and maintain assigned Standard Operating Procedures (SOPs).
  
• Conduct and review complaint investigations deviations change controls and CAPAs.
  
• Support induction and training for new hires and team members.
  
• Follow standard operating procedures and escalate exceptions to the manager/supervisor as needed.
  
• Compile interpret and present data for reports and business updates.
  
• Ensure all tasks meet standards for compliance efficiency accuracy safety and innovation as per internal and regulatory requirements.
  
• Stay current on global cGMP regulations and best practices.
  
• Represent the QA department on cross-functional project teams.
  
• Assist with the generation review and approval of Technical and Quality Agreements.
  
• Perform additional duties as assigned by the manager/supervisor.
  

Requirements

Skills and Qualifications:

• Bachelor s degree in a Quality Science or Engineering discipline (Master s degree or equivalent industrial experience preferred).
  
• Minimum of 3 years of experience in the pharmaceutical or biotech industry with a focus on cGMP quality assurance.
  
• Strong understanding of cGMP regulations and regulatory compliance for clinical supplies.
  
• Excellent verbal and written communication skills.
  
• Strong interpersonal skills and ability to work collaboratively across global teams.
  
• Proven ability to handle multiple priorities and adapt to dynamic environments.
  

Benefits