Require Regulatory Affairs Junior at Makin labs
Since its inception in 1984, today Makin labs is concentrated in 3 manufacturing facilities, located exactly at central India, Pithampur, Indore MP. The state of the art facility of Makin labs have been approved by WHO GMP – (Ayush) category certification which is 1st in central India and 8th in Nation. Makin Labs is also accredited with ISO 9001-2015, FSSAI and HALAL certificates. Being one of the fastest-growing nutraceutical company in India, we have always invested in building modern manufacturing facilities to increase our production capacities and meet the growing demands of society.
Post : Regulatory Affairs (Junior)
Job Description
• Preparation of Dossier for ROW Market.
• Hyperlink to the Common Technical Document for Dossier.
• Bookmarking to the CTD Document for Dossier.
• To review the Dossier data.
• Review of Stability Summary Report and protocol and Trend Chart.
• Review and submit Annual report data to DRA for ANDA products.
• Arrangement of sample for Regulatory Agency.
• To provide the regulatory requirement and Commitment.
• Record the Dispatch details and submission of DD.
• Review of Batch Manufacturing record and Batch packing record.
• To check standard operating procedures (SOPs) the compliance on shop floor
• Review of Technical documents.
• Drafting query-related responses.
• Coordination with the formulation development department.
Career Objective
• Coordination with QA, QC, and production
• Review and preparation of specifications and Standard test procedure.
Additional Information :
Experience - 2yrs to 5 yrs
Location - Pithampur (MP)
Qualification- B.Pharm , M.Pharm
End Date : 25th March, 2023
If interested please share your resume : recruitment@makinlaboratories.com
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