Quality Assurance 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 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.

Requirements

A contract role for a Specialist, Quality Assurance

• Responsible for activities including some or all of the following and any other tasks as required:
  
• Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business
  
• activities.
  
• Attend and successfully complete applicable cGMP training.
  
• Responds to Operational and business area’s, drives compliance with cGMP and corporate regulations.
  
• Drives cGMP/GDP compliance in the performance of day-to-day business activities.
  
• Escalate any potential violation of cGMP and/or other concerns which may affect the safety, efficacy, quality, or purity of human health products and aids resolution
  
• Liaise with the Quality/ Business Area Specialists/QP/QA Lead to resolve quality related queries where required
  
• Provides expertise & quality support for the introduction of new products onto site in relation to product release where required
  
• Ensure and promote that adequate processes and procedures are in place and followed for all Quality activities.
  
• Report on and assist with monitoring the Quality Management Systems. Generate reports for performance metrics and significant quality events & issues.
  
• Review and approval of all manufacturing batch/ material documentation
  
• including electronic batch records, real time reports, master data using the site systems where required.
  
• Identify, influence and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
  

Education:

• Bachelor's degree in Science, Engineering, Quality, Biotechnology, Pharmaceutical Sciences, Chemistry, Microbiology, or a related technical discipline.
  
• Relevant industry qualifications or certifications in Quality Management Systems, Compliance, Auditing, or Operational Excellence are desirable.
  

Experience:

• Typically 3 to 5 years' experience in a regulated pharmaceutical, biotechnology, medical device, or healthcare manufacturing environment.
  
• Demonstrated experience working within Quality Systems and Compliance
  
• functions, including management of quality records, deviations, CAPAs, change controls, investigations, Complaints and document management systems.
  
• Knowledge of current GMP requirements and quality system standards applicable to pharmaceutical manufacturing.
  
• Experience collaborating with cross-functional teams including Manufacturing, Engineering, Laboratory, Supply Chain, and Technical Operations.
  

Skills and Competencies:

• Strong understanding of Quality Management Systems and GMP compliance requirements.
  
• Excellent analytical and problem-solving skills with the ability to evaluate complex quality issues and identify sustainable solutions.
  
• Strong written and verbal communication skills, including technical writing and report preparation.
  
• Ability to manage multiple priorities and deliver results within agreed timelines.
  
• Effective stakeholder management skills with the ability to influence across functions and levels of the organization.
  
• Strong attention to detail and a commitment to maintaining data integrity and quality standards.
  
• Ability to interpret regulatory requirements and translate them into practical site procedures and processes.
  
• Proficiency in Microsoft Office applications and electronic quality management systems.
  
• Demonstrated capability to drive continuous improvement and support a culture of quality and compliance.
  

Preferred Experience

• Experience with site Quality Systems governance, metrics, compliance monitoring, and inspection readiness activities.