Deputy Manager - Pharma Process Validation & Documentation

M/s Polmon Instruments Pvt Ltd

8 - 10 years

10 - 15 Lacs

Hyderabad

Posted:1 week ago| Platform:

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Skills Required

Pharmaceutical validation PFDs EU GMP Regulatory Frameworks FDA FRS URS P&IDs IPD

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role Summary:

As Deputy Manager Automation (Pharma Process Validation & Documentation)

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

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