Quality Assurance Lead for Pharmaceutical Industry ERP Solutions

About Our Enterprise Software Solution

We are developing a state-of-the-art ERP solution tailored for the pharmaceutical industry. Our product integrates complex business processes and cutting-edge technologies to meet industry standards and drive operational efficiency.

This role plays a pivotal part in ensuring the quality, reliability, and compliance of our ERP systems designed specifically for the pharmaceutical sector. You will lead testing efforts, collaborate with cross-functional teams, and implement best practices to deliver robust software solutions that meet stringent industry standards and regulatory requirements.

Key Responsibilities:

• Test Planning & Strategy:
• Develop comprehensive test plans, strategies, and test cases based on detailed business and technical requirements.
• Define testing methodologies and processes to ensure thorough coverage of functional and non-functional requirements.
• Test Execution:
• Lead and execute functional, regression, integration, system, performance, and security testing for complex ERP modules.
• Utilize automated testing tools (e.g., Selenium, QTP) to enhance testing efficiency and coverage.
• Perform manual testing where automation is not feasible, ensuring meticulous attention to detail.
• Collaboration & Communication:
• Work closely with developers, business analysts, product managers, and other stakeholders to understand requirements and identify potential issues early.
• Participate in Agile/Scrum ceremonies, including sprint planning, daily stand-ups, and retrospectives.
• Facilitate effective communication within the QA team and across departments to ensure alignment on project goals and timelines.
• Quality Advocacy:
• Champion quality assurance best practices and foster a culture of continuous improvement within the team.
• Mentor and guide junior testers, providing training and support to enhance their skills and performance.
• Conduct code and test reviews to ensure adherence to quality standards and identify areas for improvement.
• Compliance & Documentation:
• Ensure that all testing activities comply with relevant pharmaceutical industry regulations (e.g., FDA 21 CFR Part 11, GxP).
• Maintain detailed and accurate documentation of test cases, test results, defects, and QA processes.
• Validate data migration and ensure data integrity within the ERP system.
• Issue Management:
• Identify, document, and track defects and issues using tools like JIRA or Bugzilla.
• Collaborate with development teams to prioritize and resolve issues in a timely manner.
• Verify fixes and perform regression testing to ensure issues are fully resolved.

Qualifications:

• Education:
• Bachelor's degree in Computer Science, Information Technology, or a related field.
• Advanced degree or relevant certifications (e.g., ISTQB Advanced Level) is a plus.

Technical Skills:

• In-depth knowledge of software testing methodologies, tools, and processes.
• Proficiency with automated testing frameworks (e.g., Selenium, TestNG) and scripting languages (e.g., Java, Python).
• Experience with test management and defect tracking tools such as JIRA, HP ALM, or similar.
• Familiarity with SQL and database testing.

Regulatory Knowledge:

• Strong understanding of pharmaceutical industry regulations and standards (e.g., FDA, EMA, cGMP).
• Experience ensuring software compliance with regulatory requirements, including data integrity and electronic records management.

Soft Skills:

• Excellent analytical and problem-solving abilities.
• Strong leadership and team management skills.
• Exceptional communication skills, both verbal and written.
• Ability to manage multiple priorities and work under tight deadlines.
• Detail-oriented with a commitment to delivering high-quality results.