Senior Executive - Quality Assurance (QMS)

Job Description

Key Responsibilities :

To handle Market complaints, perform investigation and protocol based study to determine root cause.

To determine the investigation plan and carry out investigations using appropriate root cause analysis tools, assessing the risk associated with them and to derive the appropriate CAPA.

To handle the recommended CAPA and to verify the implementation of recommended actions as per CAPA system and to evaluate effectiveness checks of implemented CAPA.

To handle the proposed changes as per the change control procedure. To assess the risk / impact associated with proposed change and to verify the implementation of action plan as per approved change control form

Responsible for the review of SOPs of QA department and other cross functional departments.

To perform the trend analysis of deviation, change control etc. to identify any repetitive event for further evaluation and CAPA.

To conduct or be part of team conducting risk assessment of various activities, equipment, systems, etc. and responsible for assigning the QRM no.

Handling of contract service agreement as per procedure.

To perform the self inspection of Cross functional department as per schedule and review the compliance report.

Responsible for document handling, issuance, distribution and retrieval of document.

Qualifications

Experience : minimum 5 years of Experience in handling of QMS activity in Parenteral Unit

Designation : Sr. Executive / Assistant Manager

Educational qualification : M.Pharm / B.Pharm / M.Sc.

Skills Required

Trend Analysis, Root Cause Analysis, Risk Assessment