Assistant Manager - QMS (Formulation- Liquid / Nasal)

Role & responsibilities

To manage deviations and customer complaint investigations, support audit and compliance activities, and maintain Quality Management System (QMS) documentation in line with regulatory and company requirements.

Job Responsibilities

Deliverables.

-Handle deviation and customer complaint documentation, participate in investigations, and prepare investigation reports.

-Respond to customer communications and queries related to quality issues.

-Prepare, review, and update SOPs related to customer complaints and assigned QMS activities.

-Review and evaluate QMS documents for compliance and completeness.

-Participate in customer audits and regulatory inspections and ensure effectiveness of customer complaint CAPAs.

-Prepare presentations and minutes of meetings for Management Review Meetings.

-Prepare weekly quality reports and follow up on closure of assigned actions.

-Escalate quality and compliance issues in a timely and proactive manner.

Qualifications & pre-requisites

1-B. Pharm / M. Pharm / M.Sc. (Chemistry) with relevant experience in pharmaceutical Quality Assurance.

2-trong working knowledge of QMS activities. Experience of regulatory inspections and requirements of US FDA, EU-GMP, MHRA, and TGA.

3-Knowledge of Liquid Oral dosage forms and/or potent formulations, nasal formulations; experience with OSD is supplementary, good communication skills and ability to work collaboratively.

Additional notes

1-Role is expected to work in all shifts.

2-Flexibility to take on additional responsibilities as assigned by management.