Offers “Sanofi”

Expires soon Sanofi

Assistant Manager

  • Internship
  • Hyderabad (Medak)

Job description



Mission statements

Involve and provide depth support for Regulatory inspections and Global quality audits at both Medchal and MRP sites

Duties & Responsibilities

·  Front lead runner from audit and compliance team in handling regulatory inspections/Global audits on the ground
·  Coordinate with all transversal departments regarding the inspection readiness activities- schedules and meetings with all stakeholders across transversal functions in the site  to call out scope and coverage , conduct mock inspections and document preparation as per audit/inspectors request
·  Coordinate with transversal departments for preparing the CAPA responses for inspection observations and keeping responses readiness for review post audit
·  Monitor and track the CAPA implementation related to post inspections
·  Prepare and execute the CAPA effectiveness reviews report
·  Involvement in self-inspection activities as auditors as per the schedule given by self inspection team .
·  Preparation and in use assessment of Global documents- site SOPs, Global Quality documents
·  Handling of Quality management systems like change controls, Deviations, CAPA and risk Assessments within audit and compliance team
·  Prepare and review of documents like SOPs, Record Sheets etc. in GEODE+.

Knowledge, Skills & Competencies / Language

·  Proven ability to cooperate transversally
·  Proven ability to Act for Change
·  Well-structured way of working / thinking
·  Language requirements: Fluent speaking in English, Telugu and Hindi.
·  Should have knowledge on Data Integrity principles.
·  Good knowledge on current regulatory guidelines. EU, US FDA  21 CFR WHO etc.
·  Effective coordination with cross functional teams.
·  Good documentation and technical write up skills.
·  Excellent soft skills and computer skills (MS-Office-Word, Excel & Power Point.)    

Qualifications

·  Graduate/Post graduate in Science or Pharmacy.

Requirements of the job

·  Minimum of 5-7 years’ work experience in Pharma / Biotech Quality function.
·  Should have participated in regulatory inspections i.e. USFDA, EU, and MHRA & WHO).
·  Should have exposure of performing internal audits/self-inspections.

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.

Make every future a success.
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