Assistant Manager – Quality Management System (QMS)

Sant Nirankari Enterprises; Haridwar; On-site; INR 3,000,000 - 5,000,000; Full time

Job summary

Sant Nirankari Enterprises in Haridwar, Uttarakhand is hiring a QMS Manager to lead the Quality Management System in a GMP-regulated pharma/biotech setting. The role involves ensuring compliance with GMP and regulatory requirements, maintaining SOPs and quality manuals, and coordinating audits and inspections.

Ideal candidates will have 10–15 years of QMS experience, a Post Graduate degree in a related field, and a proven track record in document control, CAPA and cross-functional coordination.

Qualifications

• 10–15 years of experience in QMS management within pharma/biotech/clinical research.
• Strong knowledge of GMP, regulatory requirements and SOPs.
• Experience preparing, reviewing, revising and maintaining quality documents and procedures.

Responsibilities

• Implement, maintain, monitor, and continuously improve the Quality Management System.
• Ensure GMP/regulatory compliance and internal quality procedures.
• Prepare, review, revise and maintain SOPs, quality manuals, policies and controlled documents.
• Coordinate internal, external, customer, and regulatory audits and inspections.
• Manage deviations, non-conformances, investigations, CAPA and root cause analysis.
• Oversee document control, change control, training records and quality documentation.
• Coordinate with QC, Production, Stores, Engineering and other departments to address quality issues.
• Monitor compliance with approved procedures and close audit observations and corrective actions.
• Support quality risk assessments and periodic QMS reviews.
• Maintain audit trails and quality documentation, assist in customer complaints investigations and quality reporting.

Education

Post Graduate (M.D.S., MD/Medicine Doctor, M.Pharma, M.Sc)

Job description

Key Responsibilities

Implement, maintain, monitor, and continuously improve the Quality Management System.

Ensure compliance with applicable Good Manufacturing Practices (GMP), regulatory requirements, and internal quality procedures.

Prepare, review, revise, and maintain Standard Operating Procedures (SOPs), quality manuals, policies, and other controlled documents.

Coordinate internal audits, external audits, customer audits, and regulatory inspections, as applicable.

Manage deviations, non-conformances, investigations, root cause analysis, and Corrective and Preventive Actions (CAPA).

Oversee document control, change control, training records, and quality-related documentation.

Coordinate with Quality Control (QC), Production, Stores, Engineering, and other departments to address quality issues.

Monitor compliance with approved procedures and ensure timely closure of audit observations and corrective actions.

Support quality risk assessments and periodic reviews of the Quality Management System.

Maintain audit trails, compliance records, and other quality documentation.

Assist in investigating customer complaints and product quality issues, where applicable.

Prepare quality reports and support management reviews and continuous improvement initiatives.

Guide team members on QMS requirements, documentation practices, and quality procedures.

• Experience

  10 - 15 Years

• No. of Openings

  1

• Education

  Post Graduate (M.D.S., MD/Medicine Doctor, M.Pharma, M.Sc)

• Role

  QMS Manager

• Industry Type

  Pharma / BioTech / Clinical Research

• Gender

  [ Male / Female ]

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office

• Face Interview Location

  Near Raja Biscuit Chowk , Jasmine Hotel , SIDCUL , Haridwar