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Officer/Sr. Officer- QA/QC Online Reviewer- Dahej

3.00 to 8.00 Years   Vadodara   04 Jun, 2023
EXTRIUS CONSULTANTS AND SERVICES Hiring For Pharma Company
Job LocationVadodara
EducationNot Mentioned
SalaryRs 3.0 - 7 Lakh/Yr
IndustryPharma / Biotech
Functional AreaR&D / Product Design
EmploymentTypeFull-time

Job Description

    Leading Pharma CompanyWe are having urgent requirement in QA/QC Online Reviewer.Kindly share profiles as per below criteria on urgent basis.Department : QA /QCDesired Position : Officer/Sr. OfficerNo. of Positions : 05Exp. Req. : 03 to 08 yearsQualification Req. : B. Pharm / M.Pharm/M.SCSalary Budget : Up to 07 Lacs ( Can Strech till 8LPA) ( 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 investigations7. 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,PriyankaExtrius Consultants & ServicesRecruitment Manager Pharma , Healthcare , Chemical & AVContact : hidden_mobileE: Priyanka@extrius.co.inURL : www.extrius.co.in

Keyskills :
lims21 cfr part 11incident investigationseu annex 11

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