Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.
Job Title: Research Scientist-Formulation Development
- Responsible for preparation of Investigation Reports as a part of Data Reliability Assessment.
- To be responsible for conducting the Technical Investigation on Market complaint’s, Incidents or any other form of Technical Investigation.
- Responsible for imparting training and shall work as training coordinator for Formulation development & Technical operations Department.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- Performs all work in support of our Corporate Values
- Works as a member of a team to achieve all outcomes.
- Supporting the other sub-ordinates in learning the departmental Quality systems and process.
- All other duties as assigned.
- To collate and compile the data pertaining to any investigation being carried out in the Formulation Development Department.
- To perform all the QMS Track wise related activities.
- To perform Technical investigations and reports if any for the closure of AQRS and Market complaints.
- Discussion with internal departments for the comments observed during Impact assessment report preparation and ensure the availability of corrected documents within time.
- To impart training and shall work as training coordinator for the Formulation Development & Technical operations department.
- To be responsible for all the activities in the Formulation Development Department including cGMP, documentation and implementation of departmental Quality systems.
- To maintain the safety and housekeeping practices at work place.
- Practice and up-gradation of knowledge with respect to cGMP.
- To carry out the activities assigned on to him / her by the concerned Research Scientist / Senior Research Scientist.
- To co-ordinate with other colleagues in the department for the necessities, in his / her role to handle the other area and getting trained.
- Education: Should be a University / College Masters Degree in Chemistry, Pharmacy, Pharmaceutical Technology, or related science.
- Experience: Should have 1 – 2 years’ experience in Technical Writing in the pharmaceutical industry and working knowledge of Formulation Development process.
- Required to have the knowledge on formulation development of Solid oral dosage forms for regulated markets like USA, Europe, Canada and Australia. Should have a good understanding of Product development process and pharmaceutical testing. Should possess good communication and interpersonal skills along with Computer efficacy in MS-Office and Internet.
- Should have good communication knowledge of English (Speaking, Reading and Writing). Should have skills in Microsoft Word, Excel and working knowledge in SAP.