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Senior Executive - QA Validation

  • Quality
  • Full-time
  • Hyderabad, IN

Posted on April 2, 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 Senior Executive - QA Validation 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:

  • Preparing protocols and schedules for qualification & requalification of our facility, equipment & utilities.

  • Cross functional coordination with other PopVax department for execution of qualifications & validations (Facility, Utility & Equipment).

  • Preparation & review of qualification protocols and trend reports.

  • Preparation & review of qualification reports and master validation plan.

  • Participation in deviation investigations to identify the root causes and define corrective and/or preventative actions.

  • Managing regulatory queries and responses from regulatory agencies, collaborators, and other interested parties.

  • Working with the rest of the QA team to ensure PopVax’s adherence to both the company’s internal protocols and to generally accepted Good Manufacturing Practices (as well as cGMP) procedures, along with regulatory (ISO, PDA, EU-GMP, WHO and 21 CFR guidelines) and safety regulations within the plant

  • Participation in the development of any validation programs needed to remain current with cGMPs and industry standards.

Candidates should have:

  • M. Pharm or equivalent from an accredited institution

  • 5-8 years of experience in a Quality Assurance role, preferably in the biotechnology and/or pharmaceutical industry, with proven expertise in validating and qualifying facilities and instruments to meet current global cGMP guidelines.

  • Proficiency in written and spoken English is required.

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.