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)