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Quality Assurance Specialist III

3 weeks, 5 days ago
India
Full-time
Mid Level
QA Engineer
Quality Assurance and Testing
Apply Now
Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 106

Description

  • Create study-specific audit schedules, audit plans, and audit reports for interim and final audits.
  • Review controlled study documents for SOP alignment, version control, and consistency with governing documents.
  • Perform QA review of clinical protocols, sample analysis protocols, and amendments for internal consistency and compliance.
  • Oversee closure of quality events related to studies at the time of data reporting.
  • Review experiment records and batch records to confirm protocol-defined activities were executed as recorded.
  • Check training status, equipment qualification, and reagent qualification during QA review.
  • Review data tables, listings, and summaries against source data for traceability, consistency, and sample ID reconciliation.
  • Apply ALCOA+ data integrity principles during review of electronic data systems.
  • Support computerized systems audits by preparing checklists, evidence lists, and pre-audit document packages.
  • Conduct data integrity audits of paper and electronic records, including audit trails, metadata, system controls, and data lifecycle controls.
  • Participate in regulatory, notified body, and customer audits as needed.
  • Provide training support for new and existing personnel and backup coverage for other Quality Specialists.

Requirements

  • Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biology, or Chemistry.
  • 4 years of related experience in a life science GxP environment, with CRO experience preferred.
  • Hands-on experience with ICH-GCP (E6 R2/R3), FDA regulations such as 21 CFR Part 11, EMA / EU CTR / Annex 11, and GxP frameworks including GCP, GMP, GLP, and GCLP.
  • Preferred certifications include ASQ Certified Quality Auditor (CQA), ISO 9001 / ISO 13485 Lead Auditor, GxP Lead Auditor (e.g., CQI/IRCA), or Clinical QA certifications (e.g., CCQAP).
  • Data review expertise across computerized systems, including LIMS.
  • Knowledge of audit trails, metadata, system validation, CSV, CSA, and data governance frameworks.
  • Ability to interpret discrepancies between raw data and reported data.
  • Proficiency with Microsoft Word, Excel, and PowerPoint.
  • Strong attention to detail, written and verbal communication skills, and the ability to work independently in a minimally supervised environment.
  • Must be able to read, write, speak, and comprehend English fluently.

Interested in this position?

Apply directly on the company website

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