Assistant Manager

8 hours ago

Bengaluru, Karnataka, India Sira Enterprises Bangalore Full time ₹ 12,00,000 - ₹ 24,00,000 per year

Job Title: Assistant Manager Quality Assurance (Oral Solid Dosage)

Department: Quality Assurance

Location: Bangalore- Harohalli

Reporting To: Manager / Head Quality Assurance

Job Overview:

The Assistant Manager – QA will be responsible for overseeing and executing qualification, validation, and Quality Management System (QMS) activities for oral solid dosage (OSD) manufacturing. The role involves ensuring GMP compliance, maintaining documentation, and supporting regulatory readiness through effective implementation of quality systems and validation programs.

Key Responsibilities:

1. Qualification & Validation

  • Plan, execute, and review equipment, utility, and facility qualification protocols (DQ, IQ, OQ, PQ).
  • Oversee process validation, cleaning validation, and analytical method validation activities as per regulatory guidelines.
  • Prepare and review validation master plans, protocols, and reports.
  • Coordinate with production, engineering, and QC for timely execution of validation activities.
  • Ensure qualification and validation documentation complies with cGMP and regulatory requirements.

2. Quality Management System (QMS)

  • Implement and maintain QMS processes such as deviation management, change control, CAPA, and document control.
  • Review and approve batch manufacturing records, SOPs, and validation documents.
  • Monitor and trend QMS metrics to identify areas for improvement.
  • Ensure compliance with data integrity and documentation standards.

3. Audits & Compliance

  • Support internal, external, and regulatory audits (e.g., WHO, USFDA, MHRA, etc.).
  • Conduct self-inspections and ensure closure of audit observations.
  • Ensure adherence to cGMP, GDP, and regulatory guidelines across departments.

4. Training & Documentation

  • Prepare and review SOPs related to qualification, validation, and QMS.
  • Train QA and cross-functional teams on validation and quality system requirements.
  • Maintain updated records of validation status and QMS performance.

5. Continuous Improvement

  • Drive improvements in validation practices and QMS efficiency.
  • Participate in risk assessments for process and equipment qualification.
  • Implement corrective and preventive actions based on audit findings and trend data.

Qualifications & Experience:

  • Education: B.Pharm / M.Pharm / M.Sc (in relevant discipline).
  • Experience: 5–8 years of experience in QA (OSD formulation) in a regulated pharmaceutical environment.
  • Strong knowledge of GMP, QMS, and regulatory guidelines (WHO, USFDA, MHRA, EU GMP).
  • Hands-on experience in qualification, validation, and quality documentation.
  • Proficiency in handling audit and compliance activities.

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