KEY ACCOUNTABILITIES 

Quality Management/Continuous Improvement 

Line Clearance and shop floor compliance 

In process checks and sampling activity 

Implementation of Zentiva corporate policies, Management and Control of Documents, such as SOPs, Master Documents, etc. 

Implementation of Complaint Investigation system at site  

Handling of Qualification and validation system, change control system, deviations 

Preparing & review the Annual Product Quality Review 

Review of Batch Reworking/Reprocessing/Reincorporation Documents 

Review of Batch Manufacturing & Packing Records 

Coordination of cGMP Training activity including training of the people 

Compliance 

Ensure adherence to company Quality Standards, Local FDA  MHRA  regulations, by 

Understanding the requirements 

Performing the Gap analysis to find out the gaps in existing system 

Preparing a compliance plan for closure of gaps 

Execution of compliance plans 

Review of completion for compliance activity 

Review of the regulatory dossiers, as and when required 

Prepare for and attend to external / regulatory Quality audits 

Validations & Qualifications: 

Preparation and review of Validation Master Plan 

Ensure validated status of all equipments, manufacturing processes, and cleaning processes 

Review of validation plans for facility / utilities / equipment / instrument / process / computer / cleaning 

Review of protocols for qualification and validation of facility/ equipment / product / process 

Review and certification of validation reports after execution of validation of facility /equipment / product / process 

Documentation Control: 

Preparation of quality system SOPs 

Controlled distribution and archival of documents & record 

Control of master documents 

Issuance of batch records and log books 

Assuring quality of products by : 

Ensuring SOP compliance 

Management of Events 

Controlling the changes made to facility / equipment / product / process and master documents by following change control procedure 

Investigation of Customer complaints / Recall 

Review of Batch Manufacturing & Packing Records 

Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints 

Ensuring the effectiveness review of the implemented CAPA 

Preparation of annual product quality review 

cGMP Training: 

To develop training modules and organize training in GMP 

Develop and execute the overall training program in coordination with all concerned departments 

Other: 

Preparation and review of site master file 

Coordinating with various agencies for making of the technical agreements 

Implementing the pest control program at Drug products 

Review of maintenance and calibration program 

Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations