QA Executive Quality Systems

Job Title: QA Executive Quality Systems

Department:

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 :

While applying please share below details.

1. Current CTC

2. Expected CTC

3. Notice period

4. Reason for job change / Ready to relocate

Equipment Qualification & Validation

6. Experience in QMS

7. Experience in QA

8. Experience in