QA CSQ CQV

About PSC Biotech Ltd

Who we are

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.

Responsibilities:

Perform other tasks as assigned by QA department:

• Accountable to provide quality oversight to validation and equipment qualification activities to ensure these activities are compliant with all applicable regulations company and contractual obligations.
  Accountable for review and approval of commissioning and qualification activities including the pre and postexecution review & approval of all validation lifecycle documents.
  Accountable for providing guidance on creation of equipment lifecycle documentation e.g. URS FAT SAT IQ OQ PQ protocols and reports risk assessments technical specifications 21 CFR Part 11 assessment Data Integrity Assessment Configuration Specifications Design specifications.Participate or lead investigation where possible related to discrepancies identified during qualification activities
  Review & approve SOPs Deviations/Event CAPAs Change Controls Periodic Maintenance plans and user access request s etc..
  Effective interfaces with internal and external stakeholders to ensure effective communication
  Align with company s Quality Goal and Strategy to set the Quality Goal as well as monitor result and employee performance
  Provide guidance to operation personnel regarding commissioning qualification and validation. Work with the team on continuous improvement activities.
  Comply with company requirements on EHS
  Perform other tasks as assigned by QA department
  

Requirements

Minimum bachelor s degree in biology biotechnology or relevant discipline

Minimum 6 years of QA experience in the biotech/pharmaceutical industry preferable in vaccine or biologics or commercial product experience CDMO experience also preferred but not required.

Good understanding of cGMP requirements GCPs GLPs GAMP and Part 11 compliance as applied to quality assurance qualification of systems and validation of biotech/pharmaceutical manufacturing processes

Excellent knowledge of validation principles

Thorough working knowledge of regulations and industry best practice affecting product quality.

Familiar with questions and challenges in audits and regulatory inspections.

Experience of working effectively in a fastpaced environment

Demonstrated problem solving and facilitation skills in daytoday practices.

Excellent written and oral communication skills able to effectively interact crossfunctionally and across all levels of the organization.