Pharm'Up 
Dr. Reddy’s Laboratories Ltd. is seeking an expert professional for the role of Team Lead – Cleaning Validation within the Manufacturing Science & Technology (MSAT) department for Oral Solid Dosage (OSD). This role is critical in ensuring that manufacturing equipment is free from cross-contamination, directly impacting patient safety and regulatory compliance.
1. Role Objective & Summary
The Team Lead will head the implementation of cleaning validation procedures and protocols. You will be the primary custodian of the Cleaning Master Validation Plan (CMVP), ensuring all OSD manufacturing processes meet global regulatory standards (FDA, EMA) and Current Good Manufacturing Practices (cGMP).
2. Key Responsibilities
- Documentation & Planning: Prepare and review Acceptance Criteria documents, Cleaning Validation Matrix, and Periodic Monitoring Schedules.
- Technical Execution: Lead swab and rinse sampling activities, identify “hard-to-clean” locations, and calculate surface areas for contact parts.
- Quality Management (QMS): Manage change controls, incident reports, and risk assessments. Ensure all CAPAs (Corrective and Preventive Actions) are closed timely.
- Audit Management: Serve as a subject matter expert (SME) during internal and external regulatory audits to explain validation strategies and data.
- Innovation: Participate in the digitalization and simplification of cleaning validation activities using specialized tools.
3. Candidate Profile
| Criteria | Requirement |
| Education | Bachelor of Pharmacy (B.Pharm) / Master’s in Science (M.Sc) or Pharmacy (M.Pharm) |
| Experience | 8 – 13 years specifically in Cleaning Validation within the Pharma industry |
| Location | Hyderabad, Telangana |
| Technical Knowledge | Familiarity with PDA Tech Report 29, ISPE, and APIC guidelines |
| Software Skills | Proficiency in CLEEN software is highly desirable |
4. Technical Skills & Critical Exposures
- Dosage Focus: Hands-on experience in Solid Dosage (OSD) forms.
- Sampling Mastery: Expert-level knowledge of swab sampling techniques and analytical data interpretation.
- Risk Assessment: Ability to perform Health-Based Exposure Limit (HBEL) assessments and derive MACO (Maximum Allowable Carryover).
- Equipment Knowledge: Experience with User Requirement Specifications (URS) and Design Qualification (DQ) related to cleaning systems.
5. Application Details
- Functional Area: R&D – General IPDO
- Industry Type: Pharma / Healthcare
- Application Deadline: 30th January 2026
About the Author
