Abbott - Assistant Manager - Quality Assurance

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 Responsibilities:

Validation & 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.