Executive I - QA, Pharma
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
REQUIREMENTS
Education / Experience
Education:
Graduate / Post Graduate in Pharmacy or Chemistry
Experience:
0 - 3years 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
