Job Description:

The job description is as below:

Purpose of the Role
To ensure timely, accurate, compliant, and scientifically justified responses to regulatory and customer queries related to pharmaceutical and medical device testing, in alignment with global regulatory and accreditation requirements.

Key Responsibilities

1. Regulatory Query Management
Receive, log, track, and respond to regulatory queries, including US FDA (483), DI queries, general correspondence, EU-GMP / PIC/S, ISO/IEC 17025 & ISO 9001 auditors, CDSCO, WHO-GMP, ANVISA, TGA, NABL assessments, Sponsor / MAH / Manufacturer technical queries. Ensure responses are technically sound, data-backed, and within committed timelines.

2. Scientific & Technical Justification
Draft scientifically justified responses related to test methods, validation/verification, OOS, OOT, deviations, investigations, Data Integrity (ALCOA+), instrument calibration & qualification, environmental monitoring & utilities data (if applicable). Coordinate with Analytical, Microbiology, and Engineering teams for factual inputs.

3.



Compliance & Documentation
Ensure all responses comply with approved SOPs, test methods, and regulatory commitments. Laboratory accreditation scope (ISO/IEC 17025). Maintain complete traceability of queries, supporting documents, and final approved responses. Archive responses as part of quality records.

4. Cross-Functional Coordination
Interface with QA, QC, Microbiology, Validation, Regulatory Affairs (client or internal), IT/Data Integrity teams. Escalate critical compliance risks to QA Head promptly.

5. CAPA & Continuous Improvement
Identify trends in regulatory queries. Support initiation of CAPA, Change Control, or Risk Assessment where gaps are identified. Participate in management reviews and audit preparedness activities.

Confidentiality & Ethics
Ensure strict adherence to confidentiality agreements (NDA), data security and information integrity. Maintain impartiality as per public tes

📌 Hiring for the position of Regulatory Query Response Officer (Ahmedabad)
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📍 Ahmedabad