Msc Chemistry Executive - Quality Assurance Post Vacancy at Sanofi

Msc Chemistry Executive – Quality Assurance Post Vacancy at Sanofi

Msc Chemistry Executive – Quality Assurance Post Vacancy at Sanofi. Chemistry Candidates with master’s degree are encouraged to apply online at Sanofi for Executive – Quality Assurance officer vacancies that are available. Sanofi is hiring Chemistry candidates for Officer vacancies. Interested candidates may apply online. Check out all the details on the same below:

Job Title:

Eligibility: M.Sc. (Chemistry)

Experience: 4 to 6 years of experience in the Pharma industry with related experience in the following fields: QC, QA, Manufacturing, Regulatory affairs.

Technical skills & Competencies / Language

  • Knowledge of GMP & Regulatory requirements.
  • Leadership skills.
  • Analytical ability.
  • Planning ability.
  • Communication skills.
  • Problem solving.
  • Team building.

KEY ACCOUNTABILITIES

Quality Management/ Continuous Improvement

Management & control of SOPs, Master documents, labels & other GMP impacted documents. Review of Batch Manufacturing Records (BMRs), Analytical record & related documentation. Deviation Investigation. Change control review & management. Batch Rework/Reprocessing Approval. Approval of repacking, relabeling & non-standard batch size procedures as per applicable SOPs.

Compliance

Ensure adherence to Corporate Quality Directives, Local FDA regulations by

  • Knowing the requirements.
  • Performing Gap analysis & making a compliance plan for closure of gaps.
  • Supporting Regulatory Affairs in related documentation.
  •  Prepare for & attend to external/regulatory quality audits.
  • Review calibration & preventive maintenance program.

Documentation Control

  • Preparations of quality system SOPs.
  • Review of other departmental SOPs.
  • To ensure controlled distribution & archival of documents & records.
  • Control change in master documents & records through change control procedure.

Assuring quality of products by

  • Ensuring compliance with applicable SOPs.

    Management of deviation/failure investigations.

  • By controlling the changes made to facility/equipment/product/process & master documents & records by following change control procedure.

  • By ensuring implementation of corrective & preventive actions proposed in deviation/ failure investigations, audit/ inspection compliance, customer complaint investigations.

    Training

    To develop cGMP training modules & impart training.

    Coordination

  • IQC (Pharmaceuticals-Ankleshwar): For testing of water for microbiological attributes, environmental monitoring, stability program & local regulatory compliance.
  • HR&A for training activity.
  • Purchase (Mumbai & Ankleshwar): For co-ordination of supplier QA activities.
  • IS- Ensure IS Compliance in coordination with IS experts.

    Other

  • Coordinating with various agencies for making of the quality agreements.
  • Implementing the pest control program at Chemistry Site.
  • Implementation of the stability program & review of the same.
  • Identifying & correcting unsafe conditions or behaviors & promptly reporting other potentially hazardous situations.

Apply Online

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