07 Nov
|
Rubicon Research
|
Satara
07 Nov
Rubicon Research
Satara
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.
Position / Job Title-Assistant manager
Department- Quality Assurance
Reporting To-Quality Assurance.
Location -Satara
Years of Experience-11-12 Year
Dosage Form-Liquid / Potent / Nasal
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, positive communication skills and ability to work collaboratively.
📌 Assistant Manager/Officer- AQA/LAB QA- Satara
🏢 Rubicon Research
📍 Satara