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, valuable 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.
Role: Quality Assurance - Other, Industry Type: Pharmaceutical & Life Sciences, Department: Quality Assurance, Employment Type: Full Time, Permanent Role Category: Quality Assurance - Other Education UG: B.Pharma in Any Specialization PG: MS/M.Sc(Science) in Organic Chemistry, Chemistry, M.Pharma in Any Specialization read more
Key Skills Skills highlighted with ‘‘ are preferred keyskills CapaChange ControlQMSDeviation Market Complaints