KRISHNAVENI MALLA

• Conducting induction trainings
• Preparation of documents for general trainings
• Preparation of training questionnaire
• Training evaluation records and track records updating
• Initiation, Uploading and revision of SOPs & formats in DMS of all departments
• Issuance of batch Records, SOPs, Formats and other document to all departments as per the request through DSRS and QMS 6.1
• Retrieval and archival of documents, logbooks and maintaining track on same
• Issuance of GTPs, STPs, any other documents as per the request
• Maintenance& Issuance of Master list of SOPs, Equipment’s, GTPs, STPs
• Assigning / deletion of equipment ID
• Maintaining the document distribution record for all documents
• Ensuring & Coordination with other departments for revision of documents as per the review schedule
• To Prepare and review of the sops and to ensure their implementation
• To ensure availability of current BPRR and BPAR prior start of manufacturing as per production schedule
• Initiation of Change controls, PNCs, Exceptions wherever required
• To support for the preparation of Annual Product Review

Conducting induction trainings

Preparation of documents for general trainings

Preparation of training questionnaire

Preparation and updating of documents for customer audits

Conducting internal audits and preparation of audit schedule

Preparation of corrective action and preventive action after audits

• Conducting induction trainings
• Preparation of documents for general trainings
• Preparation of training questionnaire
• Training evaluation records and track records updating
• Preparation of Standard operation procedures
• Filing of master documents
• Filing of previous master documents in obsolete file
• Updating of master SOP’S list
• Distribution of controlled copies to concern departments and disposal of controlled copies as per the destruction procedure
• Preparation and updating of documents for customer audits as per the audit agenda
• Team coordination for audit success
• Support for the submission of documents to the auditor within the time
• Audit Exposure: USFDA, FEMIA & Customer audits from Dr.Reddy’s, Pfizer limited, Hetero and Abbott
• Conducting internal audits
• Preparation and circulation of audit schedule one week in advance to the concerned departments
• Preparation of check list for audit