Internship: Officer- QA, Pharmacueticals
Sanofi
Ankleshwar, India
4d ago
source : Wizbii

Implement Quality Assurance activities for Pharmaceutical at Ankleshwar adhering to standard operating procedures with optimum utilization of resources to ensure consistent good quality of products to meet with customers’ requirements.

Education :

Graduate / Post Graduate in Pharmacy or Chemistry

Experience :

0 - 3 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
  • 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

    Identifying and correcting unsafe conditions or behaviours 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.

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