11 Sep
|
Care Group
|
Padra
About Company
Care Group (Est. 1987) is a global leader in ophthalmology, specialized in a strategic portfolio of parenteral and topical formulations. Our cGMP-compliant hub in Dabhasa (Padra) features advanced suites dedicated to both terminally sterilized and aseptically processed parenteral.
With a 900-strong workforce, we are seeking a leadership expert to drive operational excellence across our vertically integrated production lines. This is a promoter-led organization offering the autonomy to manage large-scale industrial capacity within a high-synergy, collaborative culture.
Position Summary
We are seeking an exceptional leader to drive operational excellence, scale manufacturing capabilities, and achieve global competitiveness while ensuring compliance with CDSCO, EMA, and EU MDR requirements.
Key Responsibilities
Oversee end-to-end manufacturing operations across all sterile/aseptic product lines
Scale production capacity to support 2X revenue growth through CMO partnerships and captive expansion
Drive Industry 4.0 transformation: automation, IoT, MES, data analytics, and AI-driven optimization
Ensure GMP compliance and maintain the highest quality standards
Manage CDSCO, EMA, EU MDR, and international regulatory audits with zero critical observations
Lead capacity expansion, technology transfers, and current product introductions
Develop and manage CMO relationships while optimizing captive production capabilities
Support export market expansion through compliance excellence and production scalability
Implement Lean Manufacturing, Six Sigma, and continuous improvement initiatives
Build and develop high-performing production teams across multiple shifts
Establish competitive benchmarking systems and drive market leadership in quality and efficiency
Required Experience & Skills
Manufacturing Expertise
12-18 years in pharmaceutical manufacturing with 5-7 years in leadership roles
Extensive experience with sterile/aseptic operations (PFS, vials, LVP, SVP)
Track record with ophthalmic or injectable product manufacturing
Experience with CMO operations and capacity scaling strategies
Preferred: Experience with top-tier companies
Required Experience & Skills (contd.)
Industry 4.0 & Technology
Proven experience leading digital transformation in pharmaceutical manufacturing
Expertise in automation, MES, SCADA, IoT, data analytics, and AI/ML applications
Regulatory Compliance
Extensive CDSCO inspection and compliance experience (Schedule M requirements)
Strong track record with FDA inspections and surveillance audits
In-depth experience with CE marking, PMA/ MAA, and Notified Body audits
Technical Competencies
Deep understanding of GMP, aseptic processing, and sterility assurance
Knowledge of validation protocols, process validation, and risk management (FMEA, HACCP)
Solid leadership, strategic thinking, and change management capabilities
📌 Plant Head (Padra)
🏢 Care Group
📍 Padra