QA Operations 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 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 clients 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 Purpose:

• Our Biologics facility have a great opportunity for a QA Operations Specialist to join the team. Reporting to the QA Operations Manager within Global Development Quality (GDQ) the QA Specialist role will support the Quality Assurance activities at Research & Development Division facility. You will be a key member of the quality team ensuring the site has a strong operational compliance focus which is aligned with the principles and expectations of cGMP regulations.
  
• Please note this is a shift role.
  
  

Requirements

Key Accountabilities:

• Liaise daily with cross-functional teams to collaboratively and actively to address compliance issues in a timely manner.
  
• Participate in investigations and risk assessments related to deviations/ complaints and changes ensuring appropriate actions are implemented to meet deadlines.
  
• Provide QA review and approval of Change Controls Deviations/CAPAs SOPs and related documentation for compliance to GMP and site requirements.
  
• Provide QA oversight to the qualification/validation technical transfers regulatory approvals laboratory operations and commercial operations.
  
• Perform material disposition of incoming material to the site.
  
• Assist in the development of training curricula and records for the QA Operations group providing SME training on Quality Assurance SOPs as required.
  
• Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
  
• Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture on site.
  
• Participate in and support risk management activities in line with relevant guidance and best industry practice.
  
• Ensure the escalation of compliance risks to management in a timely manner.
  
• Keep informed of the latest developments from regulatory authorities in relation to quality compliance.
  
• Support cross functional departments by responding to quickly to unplanned events and technical issues.
  
• Perform real time exception review by maintaining on the floor operations support during manufacturing.
  
• Support the sites walk-through/ GEMBA process as assigned.
  
• Possess knowledge of contamination control processes and assist in identifying/ mitigating contamination risks to ensure optimal product quality and compliance with regulatory standards.
  

Educational and Experience Requirements:

• Degree qualification (Science/Quality/Technical).
  
• 4-7 years experience ideally in Quality Assurance Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
  
• Experience with PAS-X SAP and Veeva is desirable.
  
• Project Manager capability with significant understanding of Operations and/or Laboratories.
  
• Demonstrated experience in QRM Investigations problem solving as a Quality SME.
  
• Strong written and verbal communication skills.
  
• Ability to think logically and be proactive under pressure.
  
• Ability to work as part of a team and on own initiative in a constructive manner. Strong attention to detail and precision in preparing and reviewing GMP documentation.
  
• Demonstrated knowledge and application of industrial regulations including those of FDA HPRA EMEA and other authorities related to Biologics and/or Pharmaceuticals.
  
• Experience in direct interactions with regulatory agencies during site inspections.
  
• Candidates must be available for flexible shift pattern & on site full time.
  
• Shift position will have a rotation of working days across 7 days max working week 40hours - start and end time will very depending on shift.