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Abbott - Assistant Manager - Quality Assurance

Abbott - Assistant Manager - Quality Assurance

Abbott Healthcare Pvt. Ltd.Goa, India
4 days ago
Job description

Job Summary :

The Assistant Manager - QA (Validation & Qualification) will lead validation and qualification activities at the site, ensuring strict adherence to cGMP, Schedule M, WHO guidelines, Abbott Quality guidelines, and internal SOPs. The role involves managing equipment / instrument qualification, process validation, QMS activities, and training to ensure a robust quality culture.

Key & Qualification :

  • Lead and execute Equipment Qualification and Instrument Qualification activities.
  • Execute Process Validation and Cleaning Validation as per regulatory and internal standards.
  • Ensure all validation documentation is prepared, reviewed, and maintained in compliance with cGMP.

Quality Systems & Compliance :

  • Ensure compliance with Schedule M, WHO guidelines, Abbott Quality Guidelines, and site SOPs.
  • Perform Acceptable Quality Level (AQL) inspections as required.
  • Support Quality Management System (QMS) activities, including change control, deviations, CAPA, and risk assessments.
  • Oversee user management and conduct audit trail reviews of production equipment and instruments.
  • Training & Documentation :

  • Deliver GMP, SOP, and technical training to site personnel.
  • Ensure robust documentation, traceability, and adherence to data integrity standards.
  • Audit & Cross-functional Support :

  • Prepare for and participate in internal and external audits.
  • Coordinate with Production, QC, Engineering, and other departments for validation-related activities.
  • Provide support for any additional QA tasks assigned by superiors.
  • Skills & Competencies :

  • Strong understanding of cGMP, Schedule M, WHO guidelines, and quality systems.
  • Hands-on experience in equipment / instrument qualification, process validation, and cleaning validation.
  • Knowledge of QMS processes (deviations, CAPA, change control).
  • Good communication and training delivery skills.
  • Attention to detail and strong documentation practices.
  • Ability to work cross-functionally and lead validation activities independently.
  • (ref : iimjobs.com)

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    Quality Assurance Manager • Goa, India

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