pharma regulatory affairs jobs – Indi Swift Laboratories
OPEN POSITIONS for Formulation Site Drug Regulatory Affairs Executive / Officer / Sr. Officer
Required Education : B Pharmacy / M Pharma
Experience : 3-5 years of experience
Location: Panchkula (3) & Gurugram (3)
Responsibilities
- Review of quality documents like API’s DMF, Finished Product Specification, Certificate of Analysis, BMR, BPR, Process Validation and Stability etc. for guidelines Compliance.
- Plan and coordinate with various departments like QA, QC and Production, to project the document requirements for appropriate submissions.
- Co-ordination with clients for the tracking and status update of project plans.
- Preparation of response to queries raised by regulatory authorities as well as by clients.
- Preparation of Product Questionnaire, MAF and all related documents for bidding of international tenders
- Literature search/survey to compile clinical and non-clinical part within registration dossiers.
- Preparation and review of SPC, Product monograph, package insert and labeling information.
- Involved in drafting & review of applications for Product Approval, CPP, MMC, Non-Conviction Certificate and FSC
- 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.
Contact Number : 70879 78441
Contact Mail : [email protected]
Address : Ind-Swift Ltd., Off. NH-21, Vill. Jawaharpur, Derabassi, Distt. Mohali, Punjab -140507