Analytical Assurance Senior Specialist

Recruiter
Sanofi
Location
India
Salary
Competitive salary
Posted
15 Sep 2020
Closes
19 Sep 2020
Ref
R2566100
Job role
Accountant
Sector
Pharmaceutical / medical
Responsibilities:

  • Monitor and ensure current Good Laboratory Practices (GLP) followed by laboratory personnel during a routine operation and ensure adherence to approved procedures.
  • Evaluate and confirm the compliance related to raw materials, in-process and finished product analytical methods and associated documents.
  • Responsible for review of all microbiological related documents of quality control.
  • Responsible for compliance of quality control (microbiology) by continuous monitoring of shop floor activities, effective review of analytical documents.
  • Supports quality control team for effective implementation of quality management system.
  • Responsible for preparation and review of microbiological related SOP's and ensuring the implementation of GLP.
  • Review and identify the gaps within the system during routine monitoring and inform the supervisor for necessary improvements in the identified areas.
  • Actively participate in laboratory investigations like out of specification/OOTs and Microbiological data deviations (e.g. Utility monitoring excursions, environmental monitoring excursion, and sterility failure investigations, etc.).
  • Responsible for review of method validation (microbiological methods) & transfers activities in line with pharmacopeial requirements.
  • Review of Specifications and STP's of raw materials, packing materials, in-process, and finished products.
  • Review of analytical reports of (microbiological tests) water, media suitability tests and product related tests.
  • Ensure execution of microbiological activities (EMP) as per plan.
  • Review of Environmental monitoring & Water monitoring trend reports.
  • Ensure a timely and detailed follow-up for all quality control related corrective and preventive actions.
  • Provide support to audit & compliance by participating in external & internal audits.
  • Review of change controls, events, CAPAs related to quality control (microbiology) department.
  • Provide training to shop- floor personnel based on requirement.
  • Assess and implement Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.

Qualification & Experience :
  • M.Sc. Biochemistry / Biotechnology with minimum 5-7 years of pharmaceutical/biotech industrial work experience.
  • Good knowledge in concepts of aseptic processing, expertise in microbiology, concepts of cleaning & disinfection, clean air environments, concepts of sterilization and sterility.
  • Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP) etc.
  • Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications.
  • Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.
  • Must be able to communicate clearly and concisely across all levels of the organization and possess a good command of English language, communication skills verbally, written, and interpersonal.


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.

Similar jobs

Similar jobs