Zentiva Hiring QA Executive in Ankleshwar | Pharma Professionals

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