Polmon - Deputy Manager - Automation Process & Documentation

Position Title: Deputy Manager

Department: Automation - Process & Documentation

Academic Qualification: B.Tech

Relevant Experience Range: 8 to 10 Years in Validation, Commissioning and Qualification in Pharma Industries (API/ Bulk / Formulation)

Location: Hyderabad

Role Summary: As Deputy Manager - Automation (Process & 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.