QA - QMS Specialist

2 days ago

Patas Pune Maharashtra, India Steribio Lifesciences Pvt Full time ₹ 2,40,000 - ₹ 4,80,000 per year

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, ₹40,000.00 per month

Benefits:

  • Provident Fund

Work Location: In person

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