Logo | XYZ Pharmaceuticals Ltd. House No.: xxx, Road.: xxx, Block: xxx, District: xxx |
JOB DESCRIPTION |
Name | Mr./Ms. XXX | |||
Functional Title | Assistant Manager, Product Development | Department | Product development | |
Location | House No.: xxx, Road.: xxx, Block: xxx, District: xxx | Date of Joining | 01.08.2021 | |
Revision No.: 00 | Page No.: 1 of 2 | |||
Relationships | ||||
Reporting to | Deputy Manager, Quality Assurance | |||
Immediate Junior Colleagues | Executive, Production | |||
Other Internal Contacts | Production, Quality Assurance & Warehouse | |||
External Contacts | Different Regulatory Authorities, Vendors & Suppliers | |||
Summary Statement: To Maintain the Product Development Department. | ||||
Major Duties & Responsibilities: 1) Management of Product Development Department, preparation of Recipe, new product as per recipe & perform as a team player conducting regular activities. 2) Core competency in Analytical Method Development of new products, Analytical Method Validation/Verification. 3) Perform the Stability protocol & Stability study of new product. 4) Preparation & development of Specification, Method, Stability protocol, AMV protocol, Cleaning Method validation & Recovery protocol for new products. 5) Preparation of regulatory documents for Product registration according to latest updates in guidelines/pharmacopeia, quality standards and regulatory requirements and ensure implementation of the same as appropriate. 6) Coordination with other internal departments to review the qualification/validation of analytical methods and analytical method transfers to Quality Control Department. 7) Perform any other assessment given by the authority. |
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 |