Officer/Sr. Officer- QA/QC Online Reviewer @ Extrius Consultants

Job Description

: ( Comments Highlighted in Green is Key Words for you)
1. Responsible for Online review of critical steps during the analysis. E.g. Solution preparation, Dilution, Solution filtration, etc.
2. Review of analytical raw data of finish products and stability studies of drug products/drug substance analysis and analytical method validation activities.
3. Review of electronic raw data and audit trails of computerized system.
4. To ensure data accuracy and correctness of the analytical data generated either manually or electronically.
5. To ensure laboratory compliance and contemporaneous documentation.
6. Experience in review of OOS/OOT and laboratory Incident investigations
7. Candidate should have basic understanding of 21 CFR Part 11 / EU Annex 11 requirements.
8. Experience working with LIMS preferable.
9. Good communication and collaboration skill who can work as a good team player.
(Candidate shall be from Pharma Formulation tablet/capsule manufacturing plant background and having experience of WHO, USFDA, MHRA, Regulatory affairs)
Note :- Local candidate will be preferred (Bharuch/Ankleshwar)

Thanks & Regards,
Priyanka
Extrius Consultants & Services
Recruitment Manager Pharma , Healthcare , Chemical & AV
Contact : hidden_mobile
E: Pr*****a@ex****s.co.in
URL : www.extrius.co.in

Employement Category:

Employement Type: Full time
Industry: Pharma / Biotech
Role Category: R&D / Product Design
Functional Area: Not Applicable
Role/Responsibilies: Officer/Sr. Officer- QA/QC Online Reviewer

Contact Details:

Company: Extrius Consultants
Location(s): Multi-City, India

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Keyskills:   lims 21 cfr part 11 incident investigations eu annex 11 online reviewer