Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.
Post : Executive - QA
Job Description:
• 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
• Must have global view, able to understand the impact of the decision on other company functions.
Quality Management/Continuous Improvement
• Line Clearance and shop floor compliance
• Implementation of Sanofi Quality Directives, Management and Control of Documents, such as SOPs, Master Documents, etc.
• Implementation of Complaint Investigation system at site
• Handling of Qualification and validation system, change control system, deviations
• Preparing & review the Annual Product Quality Review
• Review of Batch Reworking/Reprocessing/Reincorporation Documents
• Review of Batch Manufacturing & Packing Records
• Coordination of cGMP Training activity including training of the people
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
• Review of the regulatory dossiers, as and when required
• Prepare for and attend to external / regulatory Quality audits
Validations & Qualifications:
• Preparation and review of Validation Master Plan
• Ensure validated status of all equipments, manufacturing processes, and cleaning processes
• Review of validation plans for facility / utilities / equipment / instrument / process / computer / cleaning
• Review of protocols for qualification and validation of facility/ equipment / product / process
• Review and certification of validation reports after execution of validation of facility /equipment / product / process
Documentation Control:
• Preparation of quality system SOPs
• Controlled distribution and archival of documents & record
• Control of master documents
• Issuance of batch records and log books
Assuring quality of products by :
• Ensuring SOP compliance
• Management of Events
• Controlling the changes made to facility / equipment / product / process and master documents by following change control procedure
• Investigation of Customer complaints / Recall
• 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
• Preparation of annual product quality review
cGMP Training:
• To develop training modules and organize training in GMP
• Develop and execute the overall training program in coordination with all concerned departments
Other:
• Preparation and review of site master file
• Coordinating with various agencies for making of the technical agreements
• Implementing the pest control program at Drug products
• Review of maintenance and calibration program
Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations
Candidate Profile
Education: Graduate / Post Graduate in Pharmacy or Chemistry
Experience: 1-3 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirements. Implement Quality Assurance activities for Pharmaceutical at Ankleshwar adhering to global quality Directives and HSE guidelines with optimum utilization of resources to ensure consistent good quality of products to meet with customers’ requirements.
Additional Information
Experience : 1-3 years
Qualification : B.Pharm, M.Pharm, M.Sc, B.Sc
Location : Ankleshwar
Industry Type : Pharma
End Date : 30th January, 2019
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