About Apotex Inc.
Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 75 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products.
For more information visit: www.apotex.com .
Job Summary
To plan and execute the product developmental activities and to ensure proper documentation, follow procedures as per the requirements of Apotex Research Pvt. Ltd.
Job Responsibilities
- Conduct literature survey and compile the scientific findings for allocated projects.
- Plan and perform the Pre-formulation studies, and innovator product characterization
- Planning, procurement and execution of product development activities of assigned dosage forms
- Responsible to submit the samples to analytical team for evaluation and coordinate to get the data on time.
- Preparation of study protocols and reports and compilation of analytical data
- Support to execute the studies planned in external lab and monitor the execution quality.
- Conduct formula and process optimization studies for allocated projects and must be a team player.
- Prepare stability protocols as per regulatory guidelines, execute the studies and compile the results
- Execution of tech-transfer and monitoring of scale-up/exhibit/process validation batches at plant
- Coordination with vendor and internal service engineer for installation, calibration, maintenance and trouble shooting
- Support for documentation of development reports and continuous improvement procedures.
- Prepare and assist in finalization of instrument/equipment operating procedures.
- Perform daily/monthly calibrations of Lab Instruments and support for internal audits/trainings.
- Follow departmental SOPs to carryout the product development activities
- Issuance, maintenance, writing, review of raw data, completeness check and archival of laboratory notebook
- Responsible to raise PR for procurement of API, raw materials, and packing materials for development batches and receipt of same
- Report to next level manager regarding day to day activities.
Take up any other work as allotted per Department requirements
Job Requirements- Education
- M Pharma in Pharmaceutics./ Pharma/ B Tech
- Knowledge, Skills and Abilities
- Experience in handling of Liquid, Injectable, ophthalmic dosage forms is a must.
- Effective command over verbal and written communication with good interpersonnel skills.
- Proficient in MS office tools.
- Knowledge on preparation of various documents like SOPs, formats, protocols, reports etc.
- Having well versed knowledge on regulatory guidelines
- Experience in handling of Liquid, Injectable, ophthalmic dosage forms is a must.
- Able to priortise the task, best in effective planning of work activities to meet the timelines.
- Must have knowledge on handling of machinery/equipment related to parenteral dosage form
- Experience
- Minimum 3 to 6 years of experience in Injectable and Ophthalmic formulation development.
At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.
