QA Support Specialist

4 days ago

Chennai Hyderabad Secunderabad Telangana Pune, India beBeeQuality Full time US$ 90,000 - US$ 1,20,000
Job Title: QA Support Specialist

The ideal candidate will possess strong organizational and communication skills, with the ability to work effectively in a team environment.

  • We are seeking a detail-oriented individual who can assist in the preparation, issuance, review, and control of SOPs, BMRs, and controlled documents.
  • This role involves supporting the documentation of deviations, change controls, CAPA, and incidents in line with QMS guidelines.
  • As a QA support specialist, you will ensure compliance with cGMP, QMS, and regulatory requirements during all QA activities.
  • You will participate in internal audits, self-inspections, and regulatory inspections, promoting a culture of excellence and continuous improvement.
  • This position requires adherence to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available) in all documentation practices.
  • You will maintain and update QA logbooks, training records, calibration records, and archives, ensuring accuracy and completeness.
  • This role also involves supporting qualification, validation, and calibration documentation as per GMP guidelines, fostering a collaborative approach to quality management.
  • You will assist in vendor qualification processes and related documentation, further enhancing our commitment to quality and safety.
  • As a member of our EHS (Environment, Health Safety) team, you will contribute to initiatives aimed at improving workplace safety compliance and promoting a safe working environment.
  • Responsibilities include reporting any deviations, incidents, and unsafe practices immediately to supervisors, demonstrating your commitment to transparency and accountability.
  • This position offers opportunities for growth and development, enabling you to contribute to continuous improvement initiatives related to QMS, GMP, and safety standards.
  • You will support stability study documentation and ensure adherence to data integrity requirements, upholding the highest standards of quality and accuracy.

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