RK Pharma Inc. is a privately held US based company that focuses on the development, manufacturing and commercialization of high quality and affordable generic pharmaceutical products. Our core competency is Research & Complex Chemistry. Our mission is to develop, manufacture and deliver API’s, with superior quality and regulatory support, at competitive costs.

All positions are for Vadodara location

Regulatory Affairs
Experience : 10-12 years 
Qualification : M.Pharma 
Job Description :
• Review of approved vendor list in-line with submitted/current DMF.
• Review of Raw materials, Packing materials specification and analytical procedures.
• Preparation of ODMF/ Technical package as per customer requirement.
• Compilation of Drug Master Files (DMF) as per requirement / agency.
Production
Experience : 2-6 years
Qualification : M.Sc(Chemistry), B.E. (Chemical) 
Job Description :
• Handling of reactors, centrifuges, clean room
• API Manufacturing
• Prep HPLQCGMP
Sterile Production
Experience : 3-5 years 
Qualification : M.Sc/B. Pharma 
Job Description :
• Handling of sterile production activities.
• Sterilization in place activity
• Isolator activity
• Autoclave activity
• CGMP on shop floor

Quality Control
Experience : 2-5 years Qualification: M.Sc(Chemistry)
Job Description :
• Well experience on HPLC(make: waters, Shimadzu) for analysis of API, assay, RS
• Knowledge of GDP & GLP.
Quality Assurance (QA Compliance)
Experience : 4-7 years 
Qualification : M.Sc (Analytical Chemistry) / M. Pharma 
Job Description :
• Analytical Reviewer
• Knowledge of HPLC, GC & WET analysis
• Computer software validation
• Good Laboratory Practices
• Concept of GLP & GMP
EHS
Experience : 1-2 years of documentation (ISO 14001 & OHSAS 18001)
Qualification : B.Sc/M.Sc (Environmental  Science) or B.E/M.E (Env. Science)

Job Description : • Prepara tion of Legal and statutory reports, ISO 14001 & OHSAS 18001 documentation like SOPs, Manuals, risks assessment, etc.
Business Development
Experience : 8-12 years 
Qualification : B.Tech/M. Sc/M.Tech/MBA 
Job Description :
• To generate revenues from both new products & commercialised APIs
• Identifying and evaluating potential partnerships for out-licensing, in-licensing.
• To meet the annual & monthly business targets.

Share your CV at talent@apicore.com 
Last Date : 20th September 2024