Sr. Executive: QMS and Validation

Quality Management Systems (QMS)

Key Responsibilities:

Quality Management System (QMS):

• Implement, maintain, and continuously improve the site

  Quality Management System

  in line with global regulatory guidelines (WHO, USFDA, EMA, MHRA).
• Prepare, review, and update

  SOPs, quality manuals, and quality policies.

• Manage

  change control, deviation, incident reporting, and risk management

  systems.
• Coordinate and support

  internal, external, and third-party audits

  , ensuring timely

  CAPA

  implementation and closure.
• Monitor and analyze

  quality metrics

  to drive continuous improvement initiatives.
• Provide

  training and awareness programs

  for QMS procedures and

  GMP compliance

  across teams.
• Act as a key contact for

  regulatory inspections

  and customer audits.

Validation & Qualifications:

• Prepare and execute

  qualification protocols (IQ/OQ/PQ)

  for equipment, utilities, facilities, and systems.
• Lead

  process validation, cleaning validation, and computer system validation

  as per regulatory requirements.
• Develop and maintain the

  Validation Master Plan (VMP)

  .
• Ensure periodic

  requalification and revalidation activities

  are performed according to schedules.
• Review and approve all validation-related documents, including protocols and reports.
• Ensure all validation activities comply with

  cGMP, data integrity, and documentation requirements.

• Work closely with cross-functional teams (engineering, production, QC) to ensure smooth validation and qualification processes.

Qualifications & Experience:

• M.Pharm with 9-10 years of experience

  in Quality Assurance within the pharmaceutical industry.
• Strong hands-on experience in

  QMS implementation

  and

  validation/qualification activities.

• In-depth knowledge of global regulatory requirements (WHO, USFDA, EMA, MHRA).
• Strong communication, documentation, and audit-handling skills.
• Proficiency in

  MS Office (Word, Excel, PowerPoint)

  and quality documentation systems.
• Location Indore

Benefits:

• Competitive salary and performance-based incentives.
• Opportunity to work on global compliance and regulatory projects.
• Exposure to international audits and career advancement opportunities.