Apotex
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: Technical Writer-Formulation Development
Job Description:
- Preparation of various master documents required for the submission batch execution and supports the product development by preparation of documents like master production records, Master Packing records and various reports like Exhibit Batch Summary Reports, Hold Study reports, Photostability Reports, Transportation worthiness study report, Bulk product Stability Reports and other miscellaneous reports.
- Shall provide support for the system in preparation and updation of Standard Operating Procedures (SOP’s) and Formats.
- Responsible for imparting training and shall work as training coordinator for Formulation Development department.
- Preparation of Purchase indents in SAP for the procurement of raw and packing materials.
- Supporting the other sub-ordinates in learning of the departmental Quality systems and process.
- Works as a member of a team to achieve all outcomes.
- Performs all work in support of our Corporate Values Demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- All other duties as assigned.
Job Responsibilities
- To prepare various documents like SOP’s, Formats, protocols, Reports, Master formulas, SMM, SPM etc., for the Formulation Development Laboratory.
- 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 maintain online documents for the activities carried out by him / her in the area.
- To assist the Documentation officer / Senior officer in the day-to-day functioning of the Formulation Development Department.
- To impart training and shall work as training coordinator for the Formulation Development department
- To carry out the activities assigned on to him / her by the concerned Research Scientist / Senior Research Scientist.
- To collate and compile the data pertaining to any investigation being carried out in the Formulation Development Department.
- To perform Technical investigations and reports if any for the closure of AQRS and Market complaints.
- To co-ordinate with other colleagues in the department for the necessities, in his / her role to handle the other area and getting trained.
Qualifications:
- Education: Should be a University / College 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.
- Should have good communication knowledge of English (Speaking, Reading and Writing). Should have skills in Microsoft Word, Excel and working knowledge in SAP.
- Knowledge of the Pharmaceutical manufacturing Process and cGMP is desirable. Should have the attitude of performing the allotted activities in compliance with all the established procedure with an aim to develop Quality Pharmaceuticals. Should take ownership for quality in the job, support our corporate values of Pride, Accountability, Integrity and Diligence.
