Zentiva Hiring For Quality Assurance Department
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Zentiva Hiring For Quality Assurance Department |
About Zentiva
Zentiva is a producer of high-quality affordable medicines serving patients in Europe and beyond. With a dedicated team of more than 4 700 people and a network of production sites - including flagship sites in Prague, Bucharest, and Ankleshwar - Zentiva strives to be the champion of branded and generic medicines in Europe to better support people’s daily healthcare needs.At Zentiva it is our aspiration that healthcare should be a right and not a privilege. More than ever, people need better access to high-quality affordable medicines and healthcare. We work in partnership with physicians, pharmacists, wholesalers, regulators, and governments to provide the everyday solutions that we all depend on.
Zentiva Job Vacancy details:
Position: Officer - QA
Work Locations: India / Ankleshwar
Educational Qualification :
B. Pharm / M. Pharm from reputed university
Experience:
1 to 3 years similar experience in OSD manufacturing large unit.
Job Responsibilities:
Quality Management/Continuous Improvement
Line Clearance and shop floor compliance
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
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