Quality Assurance Specialist

3 days ago

Hyderabad Secunderabad Telangana Pune Chennai, India beBeeQuality Full time US$ 60,000 - US$ 1,20,000
Job Title: Quality Assurance Specialist

The Quality Assurance Specialist is responsible for ensuring compliance with cGMP, QMS, and regulatory requirements throughout all QA activities.

Responsibilities:
  • SOPs, BMRs, and Controlled Documents: Assist in preparation, issuance, review, and control of SOPs, BMRs, and controlled documents to maintain a high level of quality and integrity.
  • Documentation Management: Support documentation of deviations, change controls, CAPA, and incidents in line with QMS principles.
  • Compliance: Ensure adherence to cGMP, QMS, and regulatory requirements during all QA activities.
  • Audits and Inspections: Participate in internal audits, self-inspections, and regulatory inspections to identify areas for improvement.
  • Documentation Practices: Follow ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available) in all documentation practices.
  • Logbook Maintenance: Maintain and update QA logbooks, training records, calibration records, and archives as required.
  • Qualification and Validation: Support qualification, validation, and calibration documentation as per GMP guidelines.
  • Vendor Qualification: Assist in vendor qualification processes and related documentation.
  • EHS Initiatives: Participate in EHS initiatives and ensure workplace safety compliance.
  • Continuous Improvement: Contribute to continuous improvement initiatives related to QMS, GMP, and safety standards.
Requirements:
  • Strong understanding of cGMP, QMS, and regulatory requirements.
  • Excellent documentation skills and attention to detail.
  • Ability to work effectively in a team environment.
  • Strong communication and problem-solving skills.
  • Basic knowledge of GMP guidelines and regulations.

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