 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
