16 Aug
|
Sandoz India
|
Telangana
16 Aug
Sandoz India
Telangana
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique prospect for us all, both professionally and personally.
Summary
*The Project Quality Manager - Senior Specialist is responsible for Lead quality, validation, and IT security control assurance within Sandoz projects & programs, ensuring compliance, strong governance, and continuous improvement while enabling teams to deliver compliant, high quality outcomes. Author, review & approve system documentation, ensure compliance with policies and procedures, interface with management and stakeholders, guide project teams from a quality perspective, demonstrate the value of quality products and services, train and coach teams, and drive process improvement in the quality area.*
Major Accountabilities
- Own end-to-end quality, validation, and IT security control assurance across assigned programs/projects,
ensuring compliance with GAMP5, CSV SOPs, SDZ standards, IMF, and regulatory requirements.
- Define and execute the quality & validation strategy, including integrated security control assurance, with clear governance, deliverables, and measurable outcomes.
- Provide independent oversight and assurance through risk-based reviews, validation assessments, and security control verification, ensuring completeness, accuracy, and compliance.
- Lead and govern validation and quality execution, ensuring all qualification/validation activities are properly planned, executed, and verified through formal reporting.
- Establish and enforce documentation standards, ensuring all system and validation deliverables meet regulatory, audit, and quality expectations.
- Ensure sustained audit readiness, maintain complete, traceable evidence and proactively identify and remediate compliance gaps and findings.
- Act as a trusted adv
📌 Project Quality Manager (Telangana)
🏢 Sandoz India
📍 Telangana