Specialist, Quality Assurance - Records Management

Merck Merck · Pharma · Telangana, India

This role is responsible for the archival and lifecycle management of electronic records within a Records Management Center of Excellence (RM CoE). Key responsibilities include performing annual reviews and clean-up of archived data, supporting data retrieval requests, maintaining electronic repositories, contributing to data migration and archival projects, and producing project reports. The role requires experience in the pharmaceutical or regulated industry, familiarity with reporting tools, computer systems validation, and document control management.

What you'd actually do

  1. Perform annual reviews and clean-up of electronic archived records across RM CoE repositories to maintain accuracy, integrity, and compliance.
  2. Support archived data retrieval requests from business partners and stakeholders, delivering requested information within agreed service-level targets and assisting with audit requests as required.
  3. Maintain and monitor RM CoE-owned electronic repositories (AWS S3, file shares, SharePoint), including ongoing access control administration, routine health checks, and periodic retrieval testing.
  4. Contribute to data migration, decommissioning, retirement, and archival projects, coordinating with internal teams and external partners to ensure compliant and value-driven outcomes.
  5. Support administrative functions tied to RM CoE repositories such as documentation, change control, and configuration tracking.

Skills

Required

  • Access Control Management
  • Adaptability
  • Applied Engineering
  • Aseptic Manufacturing
  • cGMP Compliance
  • Content Management
  • Content Management Systems (CMS)
  • Data Analysis
  • Decision Making
  • Documentation Review
  • Electronic Records
  • FDA Regulations
  • Interpersonal Relationships
  • Inventory Control System
  • Inventory Management
  • Laboratory Operations
  • Laboratory Quality Control
  • Mechatronics
  • Pharmaceutical Management
  • Problem Solving
  • Quality Inspections
  • Quality Operations
  • Regulatory Compliance
  • Regulatory Inspections

Nice to have

  • Power BI
  • SharePoint
  • Excel
  • computer systems validations
  • equipment qualifications
  • document control management
  • GDP (Good Documentation Practices)
  • SOPs
  • change control processes
  • content management
  • digital validation platforms
  • inventory management systems
  • Veeva
  • ECM
  • Kneat-eVal
  • audits
  • FDA
  • ICH
  • SOX
  • GDPR
  • Multi-Language

What the JD emphasized

  • Minimum of 8+ years’ experience in the pharmaceutical environment or another regulated industry
  • Experience in computer systems validations and equipment qualifications
  • Experience in document control management with GDP (Good Documentation Practices)
  • Familiarity with regulatory requirements relevant to the industry (e.g. FDA, ICH, SOX, GDPR)