Website:
sanrabiosciences.com
Job details:
Company Description
Sanra Biosciences Pvt. Ltd. makes biomanufacturing faster, simpler, and more reliable by providing high-quality, ready-to-use liquids, including buffer solutions, process liquids, process water, and solvents.
Key Responsibilities
Document Control & Management: Manage SOPs, BMR/BPR, STPs, specifications, protocols, reports, validation/qualification documents, logbooks, risk assessments, change controls, deviations, and CAPA documentation. Handle document issuance, reconciliation, controlled copies, archiving, revision control, and master list maintenance.
In-Process Quality Assurance: Monitor floor activities such as dispensing, manufacturing, filtration, filling, visual inspection, and packaging operations, performing line clearance and process verification.
Compliance & Auditing: Support batch record reviews and release recommendations, conduct internal audits, investigate nonconformities, and maintain GMP surveillance.
Qualification & Experience
- Education: Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, Chemistry, or Microbiology (B.Pharm, M.Pharm, B.Sc., or M.Sc.).
- Experience: 2 to 5 years of executive-level experience in pharmaceuticals, biotechnology, or biomanufacturing quality functions. Additional certification in GMP documentation is preferred.
- Technical Skills: Sound knowledge of Good Documentation Practices (GDP), Data Integrity (ALCOA+) principles, GMP standards, and ISO guidelines. Proficiency in MS Office, Document Management Systems (DMS), and Pharma Cloud software or other electronic QMS platforms.
- Soft Skills: Strong written and verbal communication skills in English, with the ability to collaborate across cross-functional teams.
Click on Apply to know more.