Sanofi Analyst QA Job For Biotech, Biochem & Microbiology – Apply Online

Sanofi Analyst QA Job For Biotech, Biochem & Microbiology – Apply Online

Sanofi Analyst QA Job For Biotech, Biochem & Microbiology – Apply Online. Interested and eligible applicants can check out all of the details on the same below –

Job Title – Analyst – QA

Job ID – R2638200

Location – Medchal Mandal

Responsibilities include, but are not limited to –

• Day to day monitoring and ensuring compliance of viral vaccine manufacturing operations with EU GMP and approved site procedures with an excellent understanding of the process.
• To provide line clearance for manufacturing operations and to ensure online documentation. To be willing to work in A, B, and C shifts.
• To have good technical writing and communication skills. To independently prepare investigation reports and product impact assessments in line with international regulatory expectations.
• To involve in Failure Investigations, Out of specifications, Root cause analysis (well versed with RCA tools), environmental monitoring and water excursions with knowledge on different workflow in e-tools (e-QMS, e-doc, LIMS, SAP etc.).
• Review, approval and timely closure of Quality Management System documents (Deviations, Change controls, Out of specifications, CAPA with risk assessments).
• Ensure implementation of CAPA and its effectiveness review.
• Thorough understanding of linkage/interdependencies between different quality system elements.
• Review of SOPs, Recording sheets, Master formula records, batch manufacturing records, Protocols, Reports for Process Validation. Good understanding of simplification of complex procedures/batch records/record sheets.
• Review of Aseptic Process Simulation (APS) Protocols & Reports.
• Review of executed Batch records including analytical records. Management of retention samples.
• Preparation and review of Annual Product Quality Review (knowledge on a statistical analysis of data through JMP / Minitab etc.). Review of Environmental monitoring and Water trends.
• Ensuring the readiness for Regulatory inspections (EU) and Internal audits (Self-inspection).
• To ensure product compliance with the registered dossier.
• Responsible for identification, analysis, evaluation & documenting the risk and implementation of the appropriate mitigation plan. Preparation of Process Risk Assessments for Viral Vaccine Manufacturing Process using FMEA / any other risk assessment tool.

EXPERIENCE –

• Minimum combined seven (7) years of pharmaceutical/biotech experience in a Manufacturing or Quality role.
• Previous experience on the floor in vaccine manufacturing (cell culture, virus culture, chromatography, sterile Filtration), and exposure to aseptic environment / aseptic practices is mandatory.
• Exposure to inspections and understanding of guidelines from highly regulated market agencies like FDA, and EMEA.

​Knowledge, Skills & Competencies / Language –

• Proactive, results-oriented, and strong attention to detail.
• Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
• Strong organizational, analytical, and problem-solving skills
• Ability to analyse details and perform structured decision-making
• Ability to read, write, and speak English
• Excellent verbal and written communication including technical writing skills
• Good computer skills with basic knowledge of Microsoft office tools.

Qualifications

• Education level/degree/certification(s) required for this position- Post Graduate in biotechnology/microbiology/biochemistry.

Requirements of the job

• This position requires Minimal travel to the linked sites.
• This position may require the incumbent to be available on shifts.

APPLY ONLINE

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