Job Description
Vacancies for "QA- Regulatory" position. Interested candidates can refer below for more details:
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JOB DESCRIPTION:
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1. Line clearance ( Liquid Oral , Tablets , Capsules)
2. Responsible for monitoring In-process quality control checks in manufacturing department.
3. Comparing the description for all products against the standards.
4. Collection of samples stage wise for analysis and handover for QC Testing.
5. Checking any OOS recorded during online process and reporting to seniors.
6. Final BMR reconciliation before release for packing.
7. Preparation of Process Validation protocol & Flow charts of Tablets.
8. Preparation of presentation of products that are manufactured as a part of training.
9.To stop the line in case of any non compliance and with proper approval and guidance from seniors and HOD.
10.To reconcile the BMR and handover the final BMR for closure.
11.To know cGMP guidelines.
REGULATORY
1. Handling of documents for Export / Import NOCs.
2. Handling of documents for Additional Product Permissions.
3. Handling of documents for Certifications GMP, CoPP, FSC, NC, Capacity, Market Standing, GLP, Test Licence, CTS.
4. Knowledge about online portals of DCGI / SLA - SEVASINDHU / IDMLA / e-SUGAM.
5. Handling of documents for FSSAI licensing and Certifications with State FSSAI & Central FSSAI.
6. Handling of documents for WHO-GMP application and certifications.
7. Reviewing Stability / Validation protocols and reports.
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ELIGIBILITY CRITERIA:
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Education Qualification: B.Pharmacy/M.Pharmacy
Experience:2-6 Years
Location: Peenya, Bangalore
ONLY LOCALITIES FROM BANGALORE ARE PREFERRED