Job Description

Position Overview

We are looking for a QMS Specialist for our

Sterile Parenteral Plant (Injectables).

The role involves managing all Quality Management System activities, ensuring compliance with regulatory requirements, and supporting continuous improvement in sterile manufacturing operations.

Key Responsibilities

Manage

Change Control, CAPA, and Deviation handling

with timely closure and effectiveness verification. Prepare and review

Market Complaint investigations

and ensure compliance with regulatory timelines. Perform

Risk Assessments

to support decision-making and ensure product quality and patient safety. Ensure

compliance and timely closure of audit points

(regulatory/customer/internal). Prepare, review, and maintain

QMS documentation

including: Quality Management Procedures (QMS documents) Validation Master Plan (VMP) Site Master File (SMF) Review and ensure completeness of

Annual Product Quality Review (APQR)

reports. Review

Batch Manufacturing Records (BMR)

and

Batch Packaging Records (BPR)

for accuracy and compliance. Support regulatory and customer audits with required QMS documentation and responses. Drive continuous improvement initiatives in QMS compliance and operational excellence. Collaborate with cross-functional teams (Production, QC, Regulatory, Engineering) for timely issue resolution.

Qualifications & Experience

Education:

B.Pharm / M.Pharm / M.Sc (Microbiology, Biotechnology, Chemistry).

Experience:

2-4 years in QA/QMS function in a Sterile Parenteral / Injectable Plant. Good knowledge of

cGMP, GDocP, ICH guidelines, and regulatory compliance

(USFDA, EU, WHO, MHRA). Hands-on experience in QMS activities (Change Control, Deviation, CAPA, APQR, Market Complaints, Risk Assessment). Strong documentation, analytical, and communication skills.

Key Skills & Competencies

Knowledge of aseptic processing, sterile manufacturing, and data integrity principles. Ability to handle regulatory inspections and audits. Proficiency in MS Office and QMS software tools (Trackwise, Veeva Vault, or equivalent). Strong attention to detail, compliance mindset, and problem-solving ability.

Job Type & Level

Full-time, On-site (Patas, Pune). Designation:

QMS Specialist (QA)

Job Type: Full-time

Pay: ₹20,000.00 - ₹40,000.00 per month

Benefits:

Provident Fund
Work Location: In person

Expected Start Date: 01/09/2025