Assistant Manager -QA, Pharmaceuticals
Ankleshwar (Bharūch) Infra / Networks / Telecom
Job description
Education / Experience
Education:
Graduate / Post Graduate in Pharmacy or Chemistry
Experience:
7 - 9 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
· Must have global view, able to understand the impact of the decision on other company functions.
· Understands IA Global organization and related processes
Generic Purpose
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.
KEY ACCOUNTABILITIES
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 behaviors and promptly reporting other potentially hazardous situations.
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.