DQA

Company Description

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies.

With over 30 years of GLP compliance and certification, Eurofins Advinus serves diverse industries such as Biotech, Pharmaceutical, Biological, Agrochemical, Nutraceutical and Cosmetic. Eurofins Advinus is the only contract research organization (CRO) in India to have developed data in support of 90+ end-to-end IND enabling packages to be submitted to global regulators such as USFDA, EMA, MHRA, Health Canada and others.

Job Description

 

1. Responsible for revision, issuance of revised documents and withdrawal of superseded quality documents and obsolete the superseded documents.
2. Document control (Handling of master documents like standard operating procedures, specification & testing procedures, validation and qualification protocol, reports, batch manufacturing and cleaning records, annual product review reports etc.).
3. Preparing master list of documents.
4. Issuance of formats, registers and analytical data sheets.
5. Review of standard operating procedures related to other departments.
6. Handling of dispatch related activities.
7. Handling of Archival System.
8. Handling of Vendor Qualification.
9. Handling of Customer Queries.
10. IPQA rounds to ensure Quality System is followed in facility.
11. Preparation & review of department SOPs.
12. Login, handling/Review and approval of QMS documents (CCF, deviation, OOS, CAPA, Incident etc.)
13. Supporting for all internal and Customer audits.
14. Review and approval of ATR or COA.
15. Review of executed Lab notebook, R&D data and Analytical Report.
16. Review of Specification and Standard testing procedure.
17. Review of Equipment qualification.
18. Review and verification of Audit trail.
19. Any other activity assigned by the Department Head (wherever applicable).
20. Batch release of Finish products.
21. Review and approval of Raw Material, Packing material.

Qualifications

Experience required - 5 years

Immediate joiner or early joiner is most preferred. Msc preferred. 

Additional Information

📩 Interested candidates may send their CV to:
[email protected]

🔁 Feel free to share or refer suitable candidates in your network.