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vacancy for Fresher as Quality Assurance Officer @Sanofi

 

vacancy for Fresher as Quality Assurance Officer @Sanofi

Post : Officer – QA, Pharmacueticals

Job Description
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

Candidate profile
• Graduate / Post Graduate in Pharmacy or Chemistry
• 0 – 3 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirements
• 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

Additional Information
Experience : 0 – 3 years
Qualification : B.Sc, M.Sc, B.Pharma / M.Pharma
Location : Ankleshwar
Industry Type : Pharma
Functional Area : QA, Pharmacueticals
Job ID : R2537715
Last date : 20th June, 2020

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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