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Deputy Manager Quality Management Systems

4.00 to 7.00 Years   Hyderabad   06 Aug, 2019
Sanofi India
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaQuality (QA-QC)
EmploymentTypeFull-time

Job Description

Responsible for Global Quality Documents Alignment and should ensure the following

  • Ensuring Site gap assessment process is appropriately conducted, through:
  • Keeping informed on GQDs updates (creation, versioning, obsolescence)
  • Updating list of SMEs for global quality documents
  • Assisting the sites in the evaluation of site documentation against GQD, assessing the potential gaps and respective risk,
  • Evaluating mitigation plans when needed
  • Contributing to verify effective implementation of corrective action plans and/or compliance of updated site procedures to global quality requirements as needed
  • Tracking on-time implementation of alignment milestones (close follow-up with SMEs)
  • Documenting the reporting tool and issuing site key performance indicators on time.
  • Participating as permanent member to the Technical Standard Committee meetings
  • Escalate the identified risks as per gap assessments
  • Ensuring the in place and in use metrics
  • Participate in Documentation CoPs and regular meetings at global level
  • Ensure In use verification
Quality Risk Management (QRM):
  • To participate/perform and document risk assessments as relevant
  • To escalate the identified risks to SPIO as applicable
  • To ensure risk control and mitigation activities are in place
  • To maintain risk management documentation
  • Attend the monthly site risk review board meetings with risk update
  • Participate in QRM networking meeting and Quality risk review board meetings for sharing best partices and update of site risks
  • Prepare site SOPs and master plans linked to QRM in alignment with Global Quality Documents & regulatory requirements and ensure their in use verification.
  • Handle regular trainings on QRM at site level
Audit and Compliance:
  • To ensure all time readiness for the Global Quality audits, Regulatory audits and Customer audits.
  • Ensure the timeliness implementation of relevant CAPA.
  • Active participation in self-inspections
Preparation review and implementation of SOPs pertaining to Quality systems and Product Quality.Support Documentation activitiesContribute ideas and suggestions for improvements towards safety.Any other tasks assigned by Head of the department.
    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.,

    Keyskills :
    managementmbeddedreptingnetwking

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