• M Pharm / M Sc (Organic Chemistry) / PhD (Chemistry OR Pharmacy)


  • 8 – 10 years of experience in Production / Analytical Quality Control and/or Quality Assurance of a well-established mid-sized API Operation and/or a Pharma Plant active in Regulated / Semi-Regulated Market.


  • Of this, at least 2 – 3 years should have been as a Team Leader.


  • Should be fully conversant of the requirements of Schedule M and ICH Guidelines.


  • Should have experience in submitting DMFs and other Regulatory Applications in CTD formats.


  • Experience in having conducted Pre-Clinical Toxicity Studies preferred, not essential.


  • Must have faced Audits, of most if not all, of WHO/MHRA/TGA/US-FDA.


  • Should have good communication skills in English — written as well as verbal.


  • Should possess robust health — mind and body.




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