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Sanofi Analytical Assurance Recruitment – Biotech & Biochem Apply
Sanofi Analytical Assurance Recruitment – Biotech & Biochem Apply. Sanofi is hiring MSc Biotechnology and Biochemistry candidates with experience for Analytical Assurance Senior Specialist vacancy. Interested and eligible candidates check out all of the details on the same below:
Job Title: Analytical Assurance Senior Specialist
Job ID: R2566100
Location: Toopran Mandal
Obligations:
- Monitor and also ensure current Good Lab Practices (GLP) followed by laboratory personnel during a routine operation as well as guarantee adherence to approved procedures.
- Evaluate and confirm the compliance related to raw materials, in-process and also finished product analytical methods and also 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 the quality management system.
- Responsible for prep work and review of microbiological related SOP’s as well as guaranteeing the implementation of GLP.
- Review and also 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 as well as
- Microbiological data deviations (e.g. Utility monitoring excursions, environmental monitoring excursion, as well as sterility failure investigations, etc.).
- Responsible for review of method validation (microbiological methods) & transfers activities in accordance with pharmacopeial requirements.
- Review of Specifications and also STP’s of raw materials, packing materials, in-process, as well as 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 also comprehensive follow-up for all quality control related corrective as well as 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- flooring personnel based on the requirement.
- Assess as well as 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.
- Solid knowledge and also experience with analytical lab 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.
- Need to be proficient in computer skills and software applications such as Microsoft Office tools and also Quality applications.
- Have to have solid documentation as well as technical writing abilities, and also able to apply pertinent scientific principles as well as practices.
- Have to be able to communicate clearly and also concisely across all levels of the organization as well as have a good command of the English language, communication abilities verbally, written, and interpersonal.
Apply Online
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