Job Description

Job Location: Hyderabad
Experince: 9+Years-SME in production and inventory processes in pharmaceutical manufacturing.
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Role Overview:
We are seeking an experienced Production & Inventory Process Expert with a strong background in pharmaceutical manufacturing operations to join our NDBS team as a Domain Expert. The ideal candidate will have deep expertise in production planning, shop floor operations, and inventory management specific to pharma, but does not require SAP experience. This role focuses on providing domain insights, articulating business process nuances, and collaborating with technical teams to design and optimize solutions.
Key Responsibilities:

• Act as the subject matter expert (SME) for production and inventory processes in pharmaceutical manufacturing.
• Analyze existing business processes, identify compliance gaps, and recommend improvements aligned with GMP and regulatory standards.
• Ensure adherence to US FDA regulations, cGMP, and ICH guidelines in process design and documentation.
• Support Computer System Validation (CSV) activities and ensure compliance with 21 CFR Part 11 requirements.
• Prepare and maintain documentation to support FDA audits and other regulatory inspections.
• Work closely with solution architects and functional consultants to translate business requirements into system capabilities.
• Clearly articulate process flows, dependencies, and operational nuances to both business stakeholders and technical teams.
• Support workshops, requirement-gathering sessions, and documentation of process maps and SOPs.
• Provide guidance on KPIs, compliance standards, and operational efficiency improvements.
• Collaborate with cross-functional teams to ensure seamless integration of processes into digital solutions.

Required Skills & Qualifications:

• 8-10 years of hands-on experience in pharmaceutical production planning, shop floor operations, and inventory management.
• Strong understanding of GMP, US FDA regulations, CSV, FDA audit readiness, and other regulatory compliance requirements.
• MBA (must have) from a recognized institution.
• Excellent communication and stakeholder management skills with the ability to articulate complex business processes clearly.
• Experience in process optimization, lean manufacturing, or similar methodologies is a plus.
• Familiarity with ERP concepts (SAP, non-SAP) or other digital transformation initiatives is desirable.
• Female candidates will be accorded preference.

Industry Requirement:

• Must have experience in Pharmaceutical Manufacturing (formulation, packaging, or API production).

Preferred Background:

• Exposure to MES (Manufacturing Execution Systems), LIMS (Laboratory Information Management Systems), or other pharma-specific digital tools.
• Knowledge of batch manufacturing processes, controlled environments, and quality assurance practices.

Recruiter Email: kishore.gannapudi@bs.nttdata.com
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