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Quality Assurance Specialist III

3 hours, 32 minutes ago
India
Full-time
Mid Level
Manual QA Tester
Cybersecurity
GCP
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 105

Description

  • Create study-specific audit schedules prior to first patient-in (FIP) and develop audit plans for scheduled audits.
  • Execute internal audits and draft objective, evidence-based audit reports and summaries under QA lead oversight.
  • Review controlled documents, including SOPs, study governing documents, and versioned study materials for alignment and completeness.
  • Perform QA review of clinical protocols, sample analysis protocols (SAP/SAR), and amendments for internal consistency and SOP alignment.
  • Oversee closure of quality events tied to study data reporting.
  • Review experiment records and batch records to confirm execution matches protocol requirements, staff training status, and equipment and reagent qualification status.
  • Review data tables, listings, and summaries against data transfer agreements and source data to verify traceability and consistency.
  • Apply ALCOA+ data integrity principles when reviewing electronic data systems.
  • Support computerized systems audits by preparing checklists, pre-audit document packages, evidence lists, and document collections.
  • Participate in regulatory, notified body, and customer audits, and provide backup coverage and training support as needed.

Requirements

  • Bachelor’s degree or master’s degree in Life Sciences, Pharmacy, Biology, or Chemistry.
  • 4 years of related experience in a life science GxP environment.
  • CRO experience preferred.
  • Hands-on experience with ICH-GCP (E6 R2/R3), FDA regulations including 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 certifications such as CQI/IRCA, and clinical QA certifications such as CCQAP.
  • Strong understanding of audit trails, metadata, system validation, Computer System Validation (CSV), Computer System Assurance (CSA), and data governance frameworks.
  • Data review expertise across computerized systems, including LIMS.
  • Ability to interpret discrepancies between raw data and reported data.
  • Proficiency with Microsoft Office, including Word, Excel, and PowerPoint.
  • High attention to detail, strong written and verbal communication skills, and the ability to work independently in a minimally supervised environment.
  • Ability to meet deadlines, organize tasks, adapt to changing priorities, and perform administrative functions.
  • Must be able to read, write, speak, and comprehend English fluently.

Interested in this position?

Apply directly on the company website

Apply Now

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