QA Lead

1 week ago

Indore, Madhya Pradesh, India AppTestify Full time US$ 4,80,000 - US$ 14,40,000 per year

Job Description – QA Testing Lead

Position:
QA Testing Lead

Location:
Indore, India

Experience Required:
8+ years

Employment Type:
Full-time

Role Overview

We are seeking an experienced
QA Lead
to oversee the testing and validation of GxP/GMP-regulated computerized systems within the pharmaceutical, biotech, or life sciences domain. The ideal candidate will have a deep understanding of
Computer System Validation (CSV)
principles,
21 CFR Part 11
,
GAMP 5
, and
Annex 11
regulatory frameworks.

This role involves defining the testing strategy, managing QA teams, and ensuring all systems and applications meet compliance, quality, and business requirements through structured validation and documentation processes.

Key Responsibilities

  • Lead, mentor, and guide a team of QA testers to ensure timely and high-quality delivery of validation and testing activities.
  • Define and implement QA strategies, validation frameworks, and best practices for regulated systems.
  • Develop, review, and approve
    test plans, protocols (IQ, OQ, PQ), test scripts
    , and
    validation deliverables
    (RTM, TCR, TSR).
  • Ensure all QA activities comply with
    GxP, GMP, CSV, and data integrity
    requirements.
  • Collaborate with Business Analysts, Developers, and Validation teams to ensure traceability from requirements to testing.
  • Drive
    defect management
    and ensure timely resolution of issues with development teams.
  • Participate in
    audits and regulatory inspections
    , providing evidence of validation and QA compliance.
  • Establish and monitor
    KPIs and quality metrics
    for testing performance and compliance adherence.
  • Identify opportunities to
    automate testing
    and streamline validation processes.
  • Ensure adherence to
    SOPs, change control
    , and quality standards throughout the SDLC.
  • Provide leadership in continuous improvement initiatives to enhance QA processes and documentation quality.

Required Qualifications

  • Bachelor's degree
    in Computer Science, Information Technology, Life Sciences, or a related field.
  • 8+ years of experience
    in QA/Testing roles, with
    at least 3+ years in a QA Lead or Senior QA position
    .
  • Strong knowledge of
    GxP, GMP, CSV, 21 CFR Part 11, Annex 11, and GAMP 5
    guidelines.
  • Proven experience managing validation and testing for
    pharmaceutical or biotech systems
    (LIMS, MES, ERP, Tulip, Power Apps, etc.).
  • Expertise in preparing and reviewing
    validation documentation
    as per regulatory expectations.
  • Proficiency in
    test management and defect tracking tools
    (HP ALM/QC, Jira, TestRail).
  • Excellent understanding of
    SDLC, Agile, Waterfall, and V-model
    methodologies.
  • Strong analytical, problem-solving, and communication skills with the ability to collaborate across functions.

Preferred Skills

  • Experience with
    automation testing tools
    (e.g., Selenium, TestComplete, Tricentis Tosca).
  • Exposure to
    cloud-based and low-code/no-code platforms
    (e.g., Tulip, Power Apps, Salesforce).
  • Knowledge of
    Lean, Six Sigma, or process improvement
    methodologies.
  • Prior experience supporting
    regulatory audits
    or client inspections.

Key Attributes

  • Strong leadership and mentorship capabilities.
  • Detail-oriented with a focus on compliance and documentation integrity.
  • Ability to manage multiple projects in a regulated environment.
  • Excellent communication, planning, and stakeholder management skills.

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