Pharma Jogot
| Logo | XYZ Pharmaceuticals Ltd. House No.: xxx, Road.: xxx, Block: xxx, District: xxx |
| JOB DESCRIPTION | |
| Name | Mr./Ms. XXX | |||
| Functional Title | Manager, Quality Assurance | Department | Quality Assurance | |
| Location | House No.: xxx, Road.: xxx, Block: xxx, District: xxx | Date of Joining | 04.10.2022 | |
| Revision No.: 00 | Page No.: 1 of 2 | |||
| Relationships | ||||
| Reporting to | Plant Manager & Managing Director | |||
| Immediate Junior Colleagues | Deputy Manager, Quality Control | |||
| Other Internal Contacts | Production, Quality Control, Engineering, Product Development, Warehouse, HR & Admin, | |||
| External Contacts | Different Regulatory Authorities, Vendors & Suppliers | |||
| Summary Statement: To Maintain the Quality of the Plant. | ||||
| Major Duties and Responsibilities: 1) Ensure, the quality of all manufactured products as per cGMP. 2) Prepare, revise, and implement Standard Operating Procedures (SOP) related to quality assurance, supply chain, and production procedures. 3) To be responsible for the preparation, controlling, and archiving of different GMP documents like Site Master File, Training Manual & its Schedule, Internal and external audit schedule & maintain its Implementation, BMR, BPR, SOP, QMS documents, and all sorts of documents of Plant. 4) To be responsible for all kinds of validation-related activities for the design, commissioning, qualification & continued validation of all equipment, facility & utility. 5) Handle the QMS functions like Change Control, Deviation, non-conformities, out-of-specification, Market Complaints, Product Recall, and Risk Management. 6) Conduct GMP-related training for respective personnel as per the training calendar. 7) Ensure that the finished products have a standard approved Bill of Materials (BOM) as per approval of regulatory authority by implementing the Quality Assurance (QA) procedure in the production unit. | ||||
| Logo | XYZ Pharmaceuticals Ltd. House No.: xxx, Road.: xxx, Block: xxx, District: xxx |
| JOB DESCRIPTION | |
| Revision No.: 00 | Page No.: 2 of 2 | |
| Work Environment | Normal | |
| Work Hours | Customarily work during weekdays (48 hours work week normal) | |
| Travel | No | |
| Work Condition | Normal Work Environment | |
| Empowerment | ||
| Financial Authority | No | |
| Personnel Decision-Making Authority | No | |
| Name of Incumbent: Mr./Ms. XXX Signature of Incumbent | Name of Reporting Authority: Mr./Ms. YYY Signature of Reporting Authority | |