33 days agoSanofi

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.