MS&T Specialist III - Cleaning & Validation
Goa, India, 403722
We Are Teva
How You’ll Spend Your Day
1. Cleaning Validation Program Management
• Equipment Cleaning Program: Oversee the equipment cleaning program at the site.
• Document Review: Review technical documents related to cleaning validation from donor or transferring sites.
• Risk Assessment: Prepare and review cleaning validation risk assessments to ensure compliance.
2. Protocol & Report Management
• Protocol Development: Prepare, review, and execute cleaning validation/verification protocols and reports.
• Worst Case Matrix Development: Develop and maintain worst-case matrices and related cleaning validation/verification documents.
• Procedure Collaboration: Work with production teams to draft cleaning procedures and coordinate validation activities.
3. Collaboration & Sample Management
• QC Collaboration: Partner with Quality Control to plan analyses, manage timelines, and ensure sample flow for validation studies.
• Documentation & Compliance: Manage SOPs, change controls, investigations, CAPAs, and deviations specific to cleaning validation.
4. System Management & Communication
• System Handling: Use systems like Trackwise Harmony, Glorya EDMS, and SAP for managing validation data and documentation.
• Stakeholder Communication: Provide regular updates to key stakeholders on validation program adherence, success rates, and any issues or roadblocks.
• Project Leadership: Lead validation projects, preparing status reports as required.
5. Audit & Training Management
• Audit Participation: Support GxP audits and inspections related to cleaning validation.
• Training Completion: Complete all assigned training sessions promptly to ensure continuous compliance.
• Data Integrity Compliance: Ensure strict adherence to data integrity policies and procedures.
Your Skills and Experience
- Master’s Degree in Pharmaceutical Science
- Experience: 10 – 12 years
How We’ll Take Care of You
Teva’s Equal Employment Opportunity Commitment