仕事内容
- Responsible for leading the external audits providing the compliance in timely manners.
- To ensure GMP Compliance in the plant.
3 . To review and approve all departments Standard operating Procedure.
4 . To ensure the compliance of all Standard Operating Procedure.
5 . Strategic Planning execution of Quality Management System.
6 . To ensure the compliance of the Quality Management system as per the requirement.
7 . To review and approve the Site Manager File (SMF), Validation Master Plan(VMP) and Quality manual.
8 . Responsible for the approval and release of the Batch.
9 . To review amp; approve specifications, Standard Test Procedure (STP) and General Test Procedure (GTP) of the Quality Control Department.
10 . Responsible for Self Inspection or Internal Audit and its compliance.
11 . To review and approve all Validation and Qualification Protocols and Reports.
12 . To ensure the compliance of Vendor Audits and approval of Contract Laboratory.
13 . To impart training on different topics including cGMP and GDP etc.
14 . To coordinate during technology transfer of products to the sites.
15 . To ensure that products are manufactured as per approved procedure.
16 . Responsible for the investigation of the market complaints, Product recall amp; its compliances.
17 . Responsible for review, approval and implementation and verification of Corrective Action and Preventive Action.
19 . To provide the compliance reports of audits.
20 . To ensure the Qualification and Requalification of the Equipment, Facility and System
21 . Responsible for review and approval of Stability Protocol and report.
22 To ensure work discipline in the department.
23 . Responsible for quality agreement and its compliance.This job is provided by Shine.com