Assistant Manager/Officer- AQA/LAB QA- Satara

Rubicon Research; Satara; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Rubicon Research in Satara, India seeks an Assistant Manager in Quality Assurance with 11–12 years of pharmaceutical QA experience. The role focuses on deviations, customer complaints, QMS documentation, and regulatory compliance to meet US FDA, EU-GMP, MHRA, and TGA standards.

The candidate should have a B.Pharm / M.Pharm / M.Sc. (Chemistry) and strong knowledge of liquid oral dosage forms or potent formulations. OSD experience is a plus, enabling effective cross-functional collaboration.

Qualifications

• 11–12 years of relevant experience in pharmaceutical QA.
• Strong working knowledge of QMS activities and regulatory inspections (FDA, EU-GMP, MHRA, TGA).
• Knowledge of liquid oral dosage forms and/or potent formulations; nasal formulations; OSD knowledge is a plus.

Responsibilities

• 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.

Skills

Quality Assurance

QMS

Regulatory inspections

Education

B.Pharm / M.Pharm / M.Sc. (Chemistry)

Job description

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, good communication skills and ability to work collaboratively.