IPQA Specialist- F&F

Sanofi
  • To monitor & provide line clearance for all activities involved in compounding & filling.
  • To monitor all the shop floor activities like material management, sterilizations checks, change over in compliance with cGMP and standard operating procedures.
  • To review master formulae, protocols, reports, SOPs and annexures.
  • To prepare annul product review.
  • To review manufacturing data of the compounded & filled batches.
  • To ensure operator Qualification.
  • To provide the training to shop floor people. (as per the requirement)
  • To involve in-process validation, cleaning validations, aseptic process simulation and change over validations protocol and report preparation and execution.
  • Responsible to adherence of sampling schedules for product.
  • Review and assess the change controls, deviations, CAPAs and ensures its timely closure.
  • To ensure the log books updating and online recording of documentation.
  • To involve in scheduled self-inspections of compounding and filling areas. And ensure the closure of the observations as per the time lines.
  • To ensure the site readiness for external regulatory inspections.
  • To participate in customer complaints investigations.
  • To ensure and comply HSE requirements.To identify, correct and promptly report unsafe conditions, behaviors, or potentially hazardous situations
  • Support to RA submission.
  • Sound Knowledge in ensuring the sterile manufacturing operations,
  • Sound knowledge of concepts of Current Good Manufacturing Practices (cGMP), as well as Good Documentation Practices (GDP).
  • Ability to communicate effectively with the entire cross functional teams and complete the targets within the time duration.
  • Good verbal and written communication skills in English is required

A minimum of Bachelor's degree in science or equivalent work experience is required. A minimum of 3 plus years of experience in Pharmaceutical Quality/ Manufacturing operations is a plus. Experience in Injectable Pharmaceutical Industry is advantageous This position requires a minimum travel within and outside of India as per business requirement. This position requires working in shifts.

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.

Please note you are leaving the corporate site of Sanofi and are being redirected to our applicant tracking system, Workday, which allows you to apply to our open positions.

Please note you are leaving the corporate site of Sanofi and are being redirected to our applicant tracking system, Workday, which allows you to apply to our open positions.

More Information

Type

Junior industry position

M%C4%81ndal%2C%20India

Māndal , India

Location

India

Māndal

Type

Junior industry position

M%C4%81ndal%2C%20India