Qms Executive

Role & responsibilities

Handling of activities related to QMS.- QMS (Investigation,Change control, deviation, complaint and CAPA).

• Participate in cross functional discussion and review of Deviation Investigation,QRM , Market complaint, implementation, and monitoring of Corrective and Preventive Actions (CAPA's) to avoid re occurrence as applicable.

• To review Risk assessment for various process, investigations and activities using appropriate risk mitigation tools as applicable.

• To review the data of Quality Management Review meeting and co-ordinate for Quality Management Review meeting as per the defined frequency.

• To initiate Quality Alert Notification and Track Field Alert Notice in case of critical quality issues.

• Effectiveness verification of CAPA, Change control and Risk Assessment,Recall,Risk assessment, Management review meeting,SOP's

• Ensure timely and effective closure of QMS events associated with audit observations

• To release the batch of finished product for sale and / or distribution or reject the batch in case of any quality concerns.

• To participate in regulatory and customer audit and to submit the compliance for the observation generated during audit comply with GMP.

• To coordinate/lead in audits conducted by various regulatory bodies and customers and response preparation, review and compilation of the same in timely manner.

• Identification and implementation of the necessary quality improvement plans based on regulatory recommendation or audit compliance adherence.

• Participate in self-inspection as a member of self-inspection team.

• Ensuring overall compliance with the Site including adherence to regulatory requirements and internal policies and procedures

• All other aspects of compliance, including but not limited to GLP, GDP, GMP, etc.

• To ensure compliance w.r.t life cycle management of documents i.e. issuance, retrieval, archival, traceability and destruction of documents.

• To coordinate with colleagues working within the department and other departments to build a quality culture at site.

• To inform Qualified person (QP) or quality representative of customer in case of any Pharmaceutical quality management related issues/ tasks which includes change control, deviations, complaints etc., wherever applicable as per the respective individual procedure.

• To understand the importance of data integrity and its principles to ensure that the same is strictly followed.

Special tasks Assigned:

• Responsible for handling Market Complaints/Deviations/CAPA/Change control at site including review and approval of:

Preferred candidate profile

Expert in QMS & Market Compliance