Overview
Quality Engineering Specialist Jobs in Hyderabad, Telangana, India at SoTalent
Title: Quality Engineering Specialist
Company: SoTalent
Location: Hyderabad, Telangana, India
Job Title: Quality Engineering, QA Expert, Commissioning & Qualification Audit and Inspection Support
Location: Hyderabad, Telangana, India
Type: Full Time
Our client is seeking an experienced Quality Assurance Expert to provide strategic oversight and ensure compliance with global cGMP standards and regulatory expectations across major growth and CAPEX initiatives. This role represents Global QA in driving consistency across engineering practices, supporting inspection readiness, and strengthening quality systems throughout project lifecycles.
Key Responsibilities
- Interpret evolving regulatory expectations and inspection findings, translating them into practical quality enhancements.
- Drive resolution of audit findings and project quality review outcomes through well-structured remediation strategies.
- Facilitate collaboration across functions to implement corrective actions and track their effectiveness.
- Evaluate project execution across sites to ensure alignment with global regulatory authority standards.
- Oversee the full CAPA lifecycle, ensuring risk-based, compliant, and timely implementation.
- Review and authorize technical documentation, risk analyses, and responses to regulatory bodies.
- Promote strong data integrity practices and continuous quality improvement initiatives.
- Support audits, inspections, and commissioning/qualification activities for capital projects.
- Contribute to broader Global Quality Engineering goals as needed.
Qualifications
Education
- Degree in Engineering (Chemical/Biologics) or Life Sciences (Bachelor’s or Master’s level)
Experience
- At least 5 years of experience within a regulated pharmaceutical or biotech environment (QA, QC, Engineering, Manufacturing, R&D, or Regulatory Affairs)
- Hands-on experience in GMP-compliant API manufacturing (chemical or biological)
- Strong understanding of global regulatory frameworks (EMA, FDA, ICH, PIC/S)
- Demonstrated leadership in regulated environments
- Familiarity with commissioning, qualification, facility design controls, and audit processes
Key Skills
- Strong interpersonal and influencing abilities across multiple levels
- Effective stakeholder engagement and cross-functional collaboration
- Team leadership, coaching, and mentoring capabilities
- Excellent analytical, organizational, and problem-solving skills
- Solid understanding of API manufacturing and cGMP requirements
- Project management expertise with a focus on risk-based quality approaches
Core Competencies
- Adaptability: Embraces change, learns from challenges, and drives innovation
- Commercial Awareness: Aligns quality initiatives with business priorities and operational improvements
- Teamwork: Encourages collaboration and values diverse perspectives
- Client Focus: Builds strong relationships and anticipates stakeholder needs
- Execution Excellence: Delivers results against targets with precision and accountability
- Leadership: Inspires teams, fosters ownership, and supports professional growth
