Executive - Production ONCO (API)

Role & responsibilities

1. SAP System

1. Preparation and revision of Batch Manufacturing record (BMR), Equipment cleaning record (ECR), and Scale up report, as per requirements for Batch Manufacturing activity in plant and revise the documents as per Scale up report

2. Preparation of Scale up Report after batch execution and after proper coordination with R&D and QA department, revision of affected documents is being performed.

3. Online submission of Raw material consumption data to account department for costing purpose.

2. Documentation Activity

1. Preparation of Bill of Material (BOM) and Recipe of product in SAP system

2. Creation of order, PR generation, reservation of Raw material, packing material etc.

3. Quality Management System (QMS)

1. Proper documentation during investigation in deviation and OOS of product and apply the compliance report on affected documents.

2. Preparation of Equipment suitability, Time cycle, Risk assessments, BMR, ECR and scale up report after proper coordination with R&D team, ADL Team and Production team as per MFR and PDR.

3. Selection of Equipment, Process flow, Volume calculation, preparation of BMR and ECR as per new MFR. Currently prepared Documents for Products as per their MFR and prepare proper Mitigation plan to Assess the risk involve with the manufacturing of Product.

4. Production Activity

1. Raw material, Packing Material Issuance from Warehouse department, on time without any delay for continuous Routine production.

5. Maintain the Plant as per GMP Norms

1. Ensure that proper good housekeeping, Equipment cleaning, Area cleaning, Labelling, online documentation, in the production area for successfully complies the audit, visit, customer audit.

2. Prepare compliance report and coordinate with Respective department for resolving the issue regarding observations.                                                               

3. Successfully handling Audit with Compliance