QA Executive Quality Systems

2 weeks ago

Vadodara, Gujarat, India Hector And Streak Consulting Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Job Title: QA Executive Quality Systems

Department: Quality Assurance

Location: Vadodara, Gujarat

Key Responsibilities:

1. Quality Management System (QMS):

  • Maintain and update the QMS in compliance with GMP and regulatory standards.
  • Ensure documentation practices align with GDP (Good Documentation Practices).
  • Support implementation and continuous improvement of QMS processes.

2. Change Control:

  • Review and assess change control requests related to equipment, processes, and documentation.
  • Conduct risk assessments and impact analysis for proposed changes.
  • Ensure timely closure of change controls with proper documentation and approvals.

3. SOP Management:

  • Draft, review, and revise Standard Operating Procedures (SOPs) in coordination with relevant departments.
  • Ensure SOPs are current, compliant, and effectively implemented.
  • Train staff on new or revised SOPs and monitor adherence.

4. Audit & Compliance:

  • Prepare for and participate in internal and external audits (e.g., USFDA, WHO-GMP, ISO).
  • Address audit observations and ensure timely implementation of CAPAs.
  • Conduct self-inspections and compliance checks across departments.

5. Equipment Qualification & Validation:

  • Coordinate and document equipment qualification (IQ/OQ/PQ) and validation activities.
  • Ensure calibration and preventive maintenance schedules are followed.
  • Review validation protocols and reports for accuracy and compliance.

6. Market Complaints & Product Quality Issues:

  • Investigate market complaints and product quality issues.
  • Perform root cause analysis and implement corrective/preventive actions.
  • Communicate findings to regulatory bodies and customers as required.

Qualifications:

  • B.Pharm / M.Pharm / M.Sc. in Chemistry, Microbiology, or related field.
  • 710 years of experience in QA in a pharmaceutical manufacturing setup.
  • Familiarity with regulatory guidelines (ICH, WHO, USFDA, etc.).

Skills Required:

  • Strong understanding of GMP, GDP, and QMS principles.
  • Proficient in documentation, audit handling, and regulatory compliance.
  • Good analytical, problem-solving, and communication skills.
  • Ability to work independently and in cross-functional teams.

Note : Candidates from Baroda / Gujarat or ready to relocate with family only can apply.

While applying please share below details.

  1. Current CTC

  2. Expected CTC

  3. Notice period

  4. Reason for job change / Ready to relocate

  5. Experience in Equipment Qualification & Validation

6. Experience in QMS

7. Experience in API QA

8. Experience in GMP, GDP, and QMS principles.

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