Documentation Officer

Job Description

• Preparation of BMRs (Batch Manufacturing Record), BCRs (Batch Cleaning Record), SOP & Production related documents.
• Preparation of Process Validation protocols & reports, Cleaning Validation protocols & reports & Equipment qualification (OQ & PQ) protocols & reports.   
• To ensure and review the online entries in BMR (Batch Manufacturing Record), BCRs (Batch Cleaning Record), Equipment usage logbook and all format of Production SOP.
• Issuance of BMRs (Batch Manufacturing Record), BCRs (Batch Cleaning Record) from QA as per production planning.
• Issuance of required production formats from QA.
• To review & submit BMRs (Batch Manufacturing Record), BCRs (Batch Cleaning Record) to QA after completion of work.
• To review and submit productions protocols such as Process Validation, Cleaning validation & Equipment qualification to QA.
• To maintain and update Production Training Records of Production Persons.
• Submission & Issuance of all production documents to QA at the year end.
• To prepare yearly training calendar for production personnel.