Zentiva Hiring Executive - Quality Assurance | M Pharm / B Pharma
Zentiva,, is hiring a QA Executive in Ankleshwar. This role is ideal for individuals with a background in Pharmacy or Chemistry, combined with experience in Quality Management Systems and Regulatory Compliance. Location: Ankleshwar, Gujarat Job Role: QA Executive Experience Required: 3-8 years in Pharma Quality ManagementKEY 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