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QA Executive/Senior Executive - Biopharma QMS & Documentation

  • Quality
  • Full-time
  • Hyderabad, IN

Posted on June 3, 2024

PopVax is an Indian biotechnology company based in Hyderabad. We are funded via research agreements with the Gates Foundation and Vitalik Buterin’s biosecurity company Balvi. For the past year, we have been building a novel second-generation mRNA platform for low-cost broadly-protective vaccines via computationally-driven antigen design, starting with an open-source booster vaccine candidate that is intended to protect against the human-infecting pathogens in the betacoronavirus genus, including current and future strains of SARS-CoV-2, the virus which causes COVID-19.

We have seen up close that there are incredible capabilities in vaccine design, testing, and optimization just waiting to be unlocked that will enable us to pursue and perhaps even succeed at realizing wildly ambitious agendas such as ending TB, preventing future pandemics via broadly-protective vaccines, tackling the deadly scourge of antimicrobial resistance, eliminating debilitating degenerative diseases like multiple sclerosis, and curing fiendishly tricky chronic conditions such as ME/CFS and Long COVID. We are initiating multiple new vaccine programs this year to go after a number of these opportunities.

We are seeking a QA Executive/Senior Executive - QMS and Documentation to join our team in Hyderabad (note: in-person only, we do not offer remote work) to play a key role across our programs. Responsibilities will include:

  • Development, review, and maintenance of QA documentation, including Standard Operating Procedures (SOPs), work instructions, protocols, reports, and other quality-related documents.

  • Ensuring all QA documents are current, accurate, and compliant with regulatory and company standards.

  • Coordination of document requisition approval processes and management of document control systems.

  • Conducting regular audits/verifications of QA documentation to ensure compliance and identifying areas for improvement.

  • Providing training and support to staff on document control processes and QMS requirements.

  • Collaborating with cross-functional teams, including QC, Manufacturing, Warehouse, Engineering and Regulatory Affairs, to ensure alignment and compliance.

  • Assisting in preparing for regulatory inspections and audits, providing necessary documentation and support.

  • Maintenance of electronic and physical archives of QA documents, ensuring easy accessibility and retrieval.

  • Creating, implementing and management of change control processes for QA documentation.

  • Participating in continuous improvement initiatives related to documentation practices and quality systems (Deviations, Change Controls, CAPA and Risk Assessments etc.).

Candidates should have:

  • B. Pharm/M. Pharm, B. Tech/M. Tech in Life Sciences or equivalent from an accredited institution

  • 4+ years of experience in a Quality Assurance role, preferably in the biotechnology and/or pharmaceutical industry, with proven expertise in QA documentation and QMS.

  • Strong proficiency in written and spoken English.

This role will report to the Head of Quality Assurance.

We offer very competitive compensation, comprehensive health insurance with the option to cover immediate family (including pre-existing conditions), and, most importantly, a collaborative work environment focused on solving the cutting-edge multidisciplinary challenges of our novel mRNA platform.