AUROBINDO PHARMA LTD’ (APL). APL is a growing Indian multinational pharmaceutical manufacturing firm with turnover of over US$2.8 Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations. APL is 2nd Largest Generic Company as per Rx dispensed in the USA.APL is Amongst Top 10 Generic player in France, Germany, Portugal, UK, Italy, Czech Republic, Netherlands & Belgium.
Aurobindo Pharma is hiring for
1) Position: RA
- EU Regulatory Team (OSD)
- Qualification: Master of pharmacy in Pharmaceutics / Pharmaceutical analysis / Quality Assurance / Pharmaceutical Analysis / 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 (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 Regulatory 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.
How to Apply:
- Interested candidates send resume to this what’s app number: 8328053327
