Ind-Swift-Laboratories Ltd Walk In Interview 2022. Ind-Swift-Laboratories Ltd Notification full details below. .Interested and eligible candidates can attend interview on scheduled time and venue.Ind-Swift Laboratories Ltd. was named after the Bird “Indian Swiftlet” that is amongst the fastest flying bird in the world spending most of its life flying in air from which we derive our philosophy of inception that lies in speed, growth and persistence.
Vacancy details:.
- Post Name: Drug Regulatory Affairs Executive/Officer/Sr. Officer
- Qualification: B Pharma/ M Pharma
- Experienced:3-5 years of experience
- Skill Set: Relevant Experience in API industry
Important Details :
- Location: Gurugram
- Contact us at –91-7087978441
- Post of date:22/11/2022
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face To Face Interview
- Interview Rounds of Interview: HR
Responsibilities :
1. Preparation and review of registration dossiers as per CTD/ACTD and country specific formats.
2 Review of quality documents like API’s DMF, Finished Product Specification, Certificate of Analysis, BMR, BPR. Process Validation and Stability etc. for guidelines Compliance.
3. Plan and coordinate with various departments like QA, QC and Production, to project the document requirements for appropriate submissions
4 Co-ordination with clients for the tracking and status update of project plans. eries raised 5. Preparation of response to queries I by regulatory authorities as well as by clients.
6. Preparation of Product Questionnaire, MAF and all related documents for bidding of international tenders. 7. Literature search/survey to compile clinical and non-clinical part within registration dossiers.
8. Preparation and review of SPC, Product monograph, package insert and labeling information. 9. Involved in drafting & review of applications for Product Approval, CPP, MMC, Non-Conviction Certificate and FSC
10. Involved in preparation of renewal application for certificates like GMP, CPP WHO-GMP, GLP & Non- Conviction Certificate
Note : Only MHRA, EU GMP & ROW exposure candidates will be entertained.
Positions open in Drug Regulatory Affairs. Candidate can contact at +91-7087978441. Location Gurugram and Panchkula