Executive I - QA, Pharma (IPQA)

Generic 

Implement Quality Assurance activities for Pharmaceutical at Ankleshwar adhering to standard operating procedures with optimum utilization of resources to ensure consistent good quality of products to meet with customers’ requirements, living Group’s Values and Code of Ethics. 

Specific additions (if needed) 

Not Applicable 

KEY ACCOUNTABILITIES 

Quality Management/Continuous Improvement 

Line Clearance and shop floor compliance 

In process checks and sampling activity 

Assisting in Complaint Investigation system at site  

Assisting in Qualification and validation system, change control system, deviations 

Preparing & review the Annual Product Quality Review 

Review of Batch Manufacturing & Packing Records 

Coordination of cGMP Training activity. 

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 

Validations & Qualifications: 

Ensure validated status of all equipment’s, manufacturing processes, and cleaning processes 

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

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

Documentation Control: 

Preparation and Review of SOPs 

Controlled distribution and archival of documents & record 

Control of master documents 

Assuring quality of products by: 

Ensuring SOP compliance 

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 

cGMP Training: 

To prepare training modules and organize training in GMP 

Execute the training program in coordination with all concerned departments 

Other: 

Review of maintenance and calibration program 

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

Dimension (e.g. Budget, number of people managed) 

REQUIREMENTS 

Education / Experience 

Education: 

Graduate / Post Graduate in Pharmacy 

Experience: 

1 - 3 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirements 

Technical skills & 

Competencies / Language 

• Knowledge of GMP and regulatory requirements 

• Good interpersonal skills and able to manage conflicts 

• Believes and lives in company values 

• Skilled in team work 

• Must be able to present complicated technical issues in an easy and understandable manner and obtain appropriate actions