Junior Executive - Production Documentation

0.00 to 3.00 Years Delhi 04 Jan, 2022

Job Location	Delhi
Education	Not Mentioned
Salary	Not Disclosed
Industry	Pharma / Biotech
Functional Area	Production
EmploymentType	Full-time

Job Description

Carry out manufacturing -related documentation activities are in compliance with current Good Manufacturing Practices, Good Documentation Practices, and Data Integrity policy.
Ensure readiness of the facility at all times.
Follow all good health and hygiene practices
Preparation of Master Documents (BMR, PDR, SOP, EOP, and ECC through EDMS).
Request for Batch no. BMR/ PDR against the process order through requisition slip.
Issue of the daily checklist and ECC for production if required.
Coordination with QA, Audit lead team, Business development team during Audit/ visits.
Review of process records and production-related documents.
Identify the training need for production personnel, organize and ensure that every departments employee is trained adequately.
Ensure GMP and Hygiene within the production environment.
Drive the importance of Data integrity and compliance and through training in coordination with QA.
Plant rounds to support the manufacturing activity w.r.t any documentation requirement.
Following Standard Procedures, Safety, Health, and Environment measure continuously.
Always maintain housekeeping of the working area.
Attendance of all training sessions assigned by the training coordinator/ as per the training calendar.
Perform the activities effectively with coordination with senior persons.
Co-operation with a co-worker for completing the documentation-related activities
Focus on a good relationship with all cross-functional teams.
Initiate and closure of the deviation with the appropriate root cause and CAPA through Track wise.
Initiation of change controls of facility/process/documents through Track wise.
Complete the training in LMS before the due date.
Review of executed BMR and PDR
Submitting the TRF (Test request form) to the respective QC (Quality control) department
Review of the Audit trail in the Computerized system as per the Technical batch BMR
Submitting the executed BMR and PDR as per the standard operating procedure
Preparation of Protocol and report
Preparation of facility-related documents like URS (User requirement specification) etc.,
Closure of QMS like Change Control, CAPA (Corrective and Preventive action) and deviation,
Provide Deviation number and CAPA number for Technical batches.
Review of Technical batch BMR and PDR.
Scanning of Technical batch BMR
Reporting near miss and incident
Reporting daily status to the reporting manager
Downloading the training report from the LMS (Learning management system).
Uploading the training documents SOP/EOP/ECC and assigning them to the LMS.
Supporting for Virtual training in Microsoft Team
Updating the Classroom and Virtual training attendance in LMS

Educational Qualification: BSc Experience: 0-3 years,

Keyskills :
equal employment opportunityanimal healthmisroot causecontinuous improvement facilitationaccountsbank reconciliationsalesaudit trailaccounting

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Junior Executive - Production Documentation

Job Description

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