Aurobindo Pharma Limited Walk-in Interview. Aurobindo Pharma Limited Notification full details below. Interested and eligible candidates can attend Interview on scheduled time and venue.
Vacancy details:
Important Details :
Greetings from Aurobindo Pharma Limited
Aurobindo Pharma is hiring for
1) position..RA
EU regulatory team(0SD)..Qualification: Master of pharmacy in
1.Pharmaceutics
2.Pharmaceutical analysis
3.Quality Assurance/Pharmaceutical Analysis
4.Regulatory Affairs
Experience:3 to 16 years
Job description:✓This position is for EU regulatory team responsible for Life cycle management of Approved and tentative Approved ANDA’s/NDA’s(I
filling of supplements CBE,CBE -30,PAS, Response to Queries,controlled correspondence,Annual Reports/updates etc..)
✓ initial submissions, product life cycle management, compilations CMC,EMEA
2) position .. FRD- cost improvement projects.(osd)
Experience..3 to 8 years
Qualification..M pharmacy (pharmaceutics)
Job description..
✓Their experience with re-formulation and Cost improvement projects
✓Experience with nitrosamines, Solubility specifications,
✓Type of queries handled, ICH guidelines, Complete development process
✓Number of products in commercial stage
✓Experience in pharmaceutical research, experimentation, and data interpretation based on the analytical results .
✓Proficiency in laboratory techniques, handling of equipment’s and GMP knowledge.
✓Good knowledge on the scale-up factors from R D to EB scale.
✓Good formulation development knowledge and passion to become scientist.
✓Knowledge on the pharmacokinetics of drugs is mandatory and proficiency in BE studies is required.
✓Knowledge of regulatory requirements and quality standards in the pharmaceutical industry.
✓Excellent problem-solving, critical thinking, and communication skills
3) position ..RAD-CMC-SPD(Reviewer)
Experience..2 to 5 year’s (us regulatroy affairs)
Qualification..m pharmacy/ b pharmacy
Job description..
✓Basic knowledge for Review of Pharmaceutical Development Report.
✓Basic knowledge / hands on experience of review of manufacturing documents like batch formula, batch manufacturing records, batch packaging records, yield and reconciliation, manufacturing summaries, in-process controls data, etc.
✓Basic knowledge / hands on experience of review of analytical documents like specifications, test procedures, method equivalency reports, method validation/verification reports and method transfer reports, dissolution protocols, stability protocols, extractable & leachable study reports, etc.
✓Basic knowledge / hands on experience for preparation, review and compilation of assigned ANDAs for submission.
✓Basic knowledge / hands on experience for preparation, review and compilation of Annual Reports (ANDAs/NDAs).
✓Basic knowledge of ICH guidelines, FDA guidelines.
Knowledge of CTD modules 1,2 and 3.
Interested candidates send resume to this what’s app number …8328053327
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