Job Description

Department Details

Role Summary

Documentation & QMS Co-ordinator

Preparation/Reviewing of all quality related documents in applicable software
Initiation, coordinating with CFT and providing supporting documents for all QMS related documents (Change control, deviation, OOS, OOT, CAPA, audit management, Etc.
Provide necessary support to other department as a CFT.
Preparation / reviewing of protocol and reports including URS, equipment qualification, risk assessment, study protocol, etc., in coordination of CFT.
Responsible for assessing the gaps on existing quality documents / Records and resolve issue with proper QMS documents
Technical /Scientific support to manufacturing operations, resolution and reduction of process deviations, development and implementation of corrective / preventive actions.
Indent and receiving the BMR, ECC, Checklist, logbooks, annexures, etc., for execution.
Review and submission of executed documents like BMR, ECC, checklist, logbooks, annexures etc. To QA.
Responsible to coordinate with internal auditors and provide necessary documents.
To formalize the study / non-routine study proposed by the team and report generation, responsible for complete workflow

Key Responsibilities

Preparation/Reviewing of all quality related documents in applicable software
Initiation, coordinating with CFT and providing supporting documents for all QMS related documents (Change control, deviation, OOS, OOT, CAPA, audit management, Etc.
Provide necessary support to other department as a CFT.
Preparation / reviewing of protocol and reports including URS, equipment qualification, risk assessment, study protocol, etc., in coordination of CFT.
Responsible for assessing the gaps on existing quality documents / Records and resolve issue with proper QMS documents
Technical /Scientific support to manufacturing operations, resolution and reduction of process deviations, development and implementation of corrective / preventive actions.
Indent and receiving the BMR, ECC, Checklist, logbooks, annexures, etc., for execution.
Review and submission of executed documents like BMR, ECC, checklist, logbooks, annexures etc. To QA.
Responsible to coordinate with internal auditors and provide necessary documents.
To formalize the study / non-routine study proposed by the team and report generation, responsible for complete workflow
Responsible for assessing the gaps on existing investigation reports, risk assessment reports and other supporting reports.
Handling of Preparation, Review, Approval and Issue of Standard Operating Procedures in relevant application like DMS, FileNet.
Co-ordination for Preparation of AIM & HIRA and HAZOP study
Handling EHS violation and Process safety management
Adherence to the company for Zero tolerance policy and Code of conduct policy
To specify the requirement of zone classification during initial stage (URS) of equipment installation/project initiation.
Authorized for imparting training in QMS documents to own departmental employees and other department employees.

Educational Qualifications

Required Education Qualification: MSc.
Required Experience: 8 - 12 years

Biocon