QA Controlled Documents Senior Coordinator
Locations: Bangalore, Mumbai, Pune (Hybrid)
Job Type: Full-Time
Experience Required: 3+ years in regulatory/GxP roles
Job Overview
We are seeking a QA Controlled Documents Senior Coordinator to join our quality assurance team in India. This role is pivotal in managing controlled documents, ensuring regulatory compliance, and supporting overall quality assurance (QA) objectives. The ideal candidate will have 3+ years of experience in a regulatory or GxP environment and demonstrate strong analytical, organizational, and communication skills.
This hybrid role offers exposure to multiple regulatory environments and provides opportunities to contribute to document control, compliance tracking, and process improvement initiatives.
Key Responsibilities
Administer and manage controlled documents, ensuring availability and accessibility for end users.
Follow departmental Standard Operating Procedures (SOPs) and Work Instructions (WIs) accurately.
Complete all required trainings within defined timelines.
Track, monitor, and report document metrics according to management requirements.
Assist in implementing new or revised processes and procedures for document control.
Perform quality checks to ensure accuracy, completeness, and compliance of documentation.
Escalate and resolve issues impacting controlled document release in a timely manner.
Ensure compliance with Regulatory Compliance (RC) and QA responsibilities as defined in applicable controlled documents.
Communicate effectively with cross-functional teams to support documentation processes.
Support additional QA initiatives and responsibilities as assigned.
Candidate Profile
Education & Experience:
Minimum 3 years of experience in a regulatory environment, preferably in GxP roles.
Experience in document control, regulatory compliance, and QA operations.
Skills & Competencies:
Strong analytical skills and attention to detail.
Ability to plan, prioritize, and organize tasks effectively.
Proficient in MS Office and other departmental tools.
Strong interpersonal and communication skills, capable of working collaboratively.
Ability to maintain consistent high-quality output.
Work Environment:
Comfortable working in hybrid setups with tasks involving prolonged computer use.
Willingness to work 2nd shift hours (2 PM – 11 PM IST) if required.
Why Join Us
This role provides career growth opportunities in pharmaceutical QA and regulatory affairs. You will gain hands-on experience in controlled document management, compliance tracking, and QA operations, contributing to high-quality regulatory submissions and process improvements.
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