Deputy Manager - Pharma Process Validation & Documentation M/s Polmon Instruments Pvt Ltd

8.0 - 10.0 years

10 - 15 Lacs

Hyderabad

Work from Office

Role Summary: As Deputy Manager Automation (Pharma Process Validation & Documentation) , you will lead validation strategy, customer interfacing, and cross-functional coordination to ensure seamless project execution and regulatory compliance. This role demands strong technical acumen, leadership capability, and the ability to drive results across departments in a regulated pharmaceutical environment. Key Responsibilities: Lead project documentation and automation activities, ensuring timely execution and alignment with customer requirements. Manage end-to-end coordination for CRMs and KOMs preparing agendas, driving discussions, and capturing actionable outcomes. Define and implement validation strategies and master plans (VMP) in compliance with FDA, EU GMP, WHO guidelines. Oversee validation document preparation ( URS, IPD, PFDs, P&IDs, and FRS ) and ensure timely customer approvals. Supervise and mentor the validation team, ensuring training, performance tracking, and continuous improvement. Maintain compliance with Good Documentation Practices ( GDP ); manage SOP updates and audit readiness. Lead risk assessments ( FMEA ), impact analysis, and closure of deviations/ CAPAs under change control processes. Collaborate with QA, Engineering, R&D, and Project teams to ensure project and validation alignment. Monitor validation progress, analyze results, and present regular status reports to senior management. Represent validation activities during audits and regulatory inspections. Required Skills: Strong understanding of pharmaceutical validation, automation processes , and regulatory frameworks Proven leadership and team management abilities Excellent communication, presentation, and stakeholder engagement skills Strategic thinking with a focus on compliance and on-time delivery Proficiency in MS Office and technical documentation systems

Posted 1 week ago

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