Maithri Drugs is one of India's fast-growing pharmaceutical companies. Maithri's strategic focus is on active pharma ingredients (APIs). The company is widely recognized for its excellent research & development and aggressive growth strategies. Our 32 US DMFs and 9 CEPs in a short span attest to our R&D excellence.
Post : Executive’s
Qualification : M.Sc (Chemistry)/ M.Pharm
Eligibility Criteria : 1-3 yrs of work experience in pharma industry.
JOB SPECIFICATIONS
A. DQA :
1. Reviewing of Laboratory Note Books, Analytical method development documents, R&D final process, Structure conformation reports, Development reports and should archive in systematic manner.
2. Reviewing of Standard Operating Procedures for all the departments and new developing process proposals.
3. Responsible for ensuring the license requirements for new drug substance.
4. Filling and preparation of vendor questionnaires from the customers.
5. Preparation of technical packages as per the requirements.
6. Need to handle change controls, need to maintain change controls log books and should review histories for all the documents.
7. Responsible for new raw materials supplier qualification activities.
8. Responsible for technology transfers from R&D to Plant.
B. RA :
1. Should compile the DMF’s (Drug master file) in eCTD format.
2. Preparation and submission of Technical packages, Amendments/revisions, Annual reports, Applicant part, Restricted part and Deficiency responses to respective regulatory authorities.
3. Need to review the analytical related documents and process development reports.
4. Need to evaluate the proposed changes w.r.t post approval changes guidelines.
DOCUMENTS TO BE CARRIED : Candidates are requested to carry updated resume, photocopies of educational certificates, latest increment letter, last 3 months pay slips, last 6 months bank statement, photocopy of aadhar card and pan card.
DATE : 06/11/2021
TIMINGS : Interested candidates may walk-in from 09:00 AM to 01:00 PM
INTERVIEW MODE : Face to Face interview for experienced candidates
INTERVIEW VENUE & JOB LOCATION : Maithri Drugs R&D Technology Center, Gummadidala. Landmark: 2nd gate beside IPC Church, Gummadidala
Note 1 : Candidates are requested to carry updated resume, photocopies of educational certificates, latest increment letter, last 3 months pay slips, last 6 months bank statement and photocopy of aadhar card.
Note 2 : For SELECTED candidates we provide free transport from Balanagar X Roads/Kukatpally and subsidiary canteen food.
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