Officer

Purpose

To manage, maintain, and improve Quality Management System (QMS) documentation in compliance with regulatory requirements such as USFDA, EU-GMP, WHO-GMP, and ICH guidelines.

Position / Job Title

Officer

Department

Manufacturing

Reporting To

HOD

Location

Satara

Years Of Experience

7-8 Years

Dosage Form

Oral liquid formulation

Job Responsibilities / Deliverables

Preparation, review, approval, and control of QMS documents like SOPs, STPs, Change Controls, Deviations, CAPA, OOS/OOT.

Ensure Compliance With Regulatory Guidelines (USFDA, EU-GMP, WHO).

Support internal and external audits by providing QMS documentation.

Review and implement regulatory and corporate quality requirements.

Conduct QMS-related training for site personnel.

Support continuous improvement initiatives within the QMS.

Coordination with cross-functional teams (QC, Production, Validation, RA).

Handling electronic QMS (eQMS) systems, if applicable.

To ensure safety, hygiene and maintain c-GMP environment during manufacturing and cleaning process.

Qualifications & Pre-Requisites

Education: B.Pharm / M.Pharm

Experience: 7–8 years in Pharma

Strong Knowledge Of

QMS documentation systems

Regulatory inspections and audit readiness

Data integrity principles (ALCOA+)

Additional Notes

Excellent documentation and technical writing skills

Strong understanding of regulatory compliance

Good communication and coordination skills

Hands-on experience with eQMS tools is an advantage