2 years

3 - 4 Lacs

Posted:5 days ago| Platform: GlassDoor logo

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Work Mode

On-site

Job Type

Full Time

Job Description

Job Summary:

We are seeking a detail-oriented and experienced QA – QMS Specialist to support and maintain our Quality Management System (QMS). This role is critical in ensuring our organization remains compliant with industry standards and regulatory requirements. The ideal candidate will have a strong understanding of QMS processes, document control, audits, CAPA systems, and continuous improvement methodologies.

Key Responsibilities:

  • Manage and maintain QMS documentation, including SOPs, work instructions, and quality records
  • Support internal and external audits (ISO, FDA, customer, etc.)
  • Monitor and track non-conformances, deviations, CAPAs, and change controls
  • Collaborate with cross-functional teams to ensure QMS compliance and improvement
  • Assist in training staff on quality procedures and QMS updates
  • Prepare reports and metrics related to QMS performance and trends
  • Ensure compliance with regulatory and industry standards such as ISO 9001, ISO 13485, FDA 21 CFR Part 11/820, or other applicable standards
  • Participate in root cause analysis and risk assessments

Qualifications:

  • Bachelor’s degree in a science, engineering, or quality-related field (preferred)
  • 2–7 years of experience in QA/QMS within Pharmaceuticals industry
  • Solid knowledge of QMS frameworks (e.g., ISO, FDA, ICH Q10)
  • Experience with audit preparation and hosting
  • Proficient in quality tools such as CAPA, FMEA, and RCA
  • Strong organizational and communication skills
  • Familiarity with electronic QMS software (e.g., Master Control, Veeva, Track Wise) is a plus

Interested candidates share me your on rahul@gmh.co.in

Job Types: Full-time, Permanent

Pay: ₹25,000.00 - ₹40,000.00 per month

Benefits:

  • Cell phone reimbursement
  • Flexible schedule
  • Food provided
  • Health insurance
  • Internet reimbursement
  • Leave encashment
  • Life insurance
  • Paid sick time
  • Paid time off
  • Provident Fund

Work Location: In person

Speak with the employer
+91 7876456719

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