Qualification & Validation Specialist, Report Issuance Sanofi

2 - 5 years

0 - 1 Lacs

Hyderabad

Hybrid

Qualification & Validation Specialist, Report Issuance Location: Hyderabad About the job Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions, in human vaccines, rare diseases, multiple sclerosis, oncology, immunology, infectious diseases, diabetes and cardiovascular solutions. As a company with a global vision of drug development and a highly regarded corporate culture, Sanofi is recognized as one of the best pharmaceutical companies in the world and is pioneering the application of Artificial Intelligence (AI) with strong commitment to develop advanced data standards to increase reusability & interoperability and thus accelerate impact on global health. The Global M&S Services acts as a cornerstone to this effort. Our team is responsible for delivering and supporting Global M&S teams by acting as a crucial link between our R&D and Manufacturing facilities, playing a vital role in securing the present portfolio and delivering future launches of high-quality and innovative drugs and vaccines. Main responsibilities: Include references to relevant documents essential for the qualification process. Finalize qualification protocols and reports by adjusting layout and format to meet organizational standards and regulatory requirements Communicate the approval of qualification protocols and updates to all relevant stakeholders via Content Management Systems (CMS), ensure timely dissemination of information and update. Schedule formal consolidated review and approval meetings for qualification protocols Launch and manage the review workflow in CMS, tracking progress and ensuring deadlines are met. Collaborate closely with the Global Qualification Team Lead, Expert, and Specialist to support qualification activities Ensure all documentation complies with overall documentation standards. Identify opportunities for process improvement in document management and workflow efficiency and implement enhancements to streamline qualification protocol finalization and communication processes About you: Experience: Professional experience in general documentation and project management. Soft skills: Proficient in problem-solving, attention to detail, and good organizational skills. Ability to work collaboratively with cross-functional teams in a flexible and proactive manner. Strong analytical skills. Agile thinker and learner, adaptable to complex & dynamic environments. Technical skills: CMS, Quality systems (e.g., Veeva, Kneat), Word, Excel, Power Point. Education: Bachelors degree in business administration, life sciences, or a related field. Languages: Excellent English communication and writing, French or other Languages in addition preferred

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Engineering Electrical Proces - Sr. Executive / Executive AET Laboratories

6 - 8 years

5 - 7 Lacs

Hyderabad

Work from Office

Role & responsibilities 1.Machinery Breakdown Management. 2. Operation and Preventive Maintenance. 3. SOP Preparation and Documentation. 4.Training and Development. 5.Equipment Qualifications. 6.Documentation and Data Management. 7.Material Coordination. Description: Attend or delegate personnel to attend machinery breakdowns promptly Monitor and verify the operation, preventive maintenance, and troubleshooting of process equipment. Responsible for qualifications (IQ, OQ, PQ), requalification, and revalidations of process equipment.

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Quality control chemical Manager-stability Ruchita Hiraji Thakur

7 - 10 years

10 - 15 Lacs

Halol

Work from Office

Preparation& Review of stability study protocols,reports, summery sheet for all the products ( General Injectable &OSD) cross functional with R &D,QA,Prodcution etc. ,GMP/SOP training QC Activities ADL/Oncology & General Block Qualification/issuance

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