Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations. Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc.
Apply online:End Date : 30th November 2024
Location : Bangalore, KA
Qualification : M.Pharm, B.Tech
Industry Type : Pharma / Healthcare / Clinical research
Experience : 3 to 6 years
Job Description
To plan and execute the product developmental activities and to ensure proper documentation, follow procedures as per the requirements of Apotex Research Pvt. Ltd.
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
Candidate Profile
• M.Pharma in Pharmaceutics./ Pharma/ B.Tech
• 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
• Minimum 3 to 6 years of experience in Injectable and Ophthalmic formulation developme
For More JOB Updates Join Our Whatsapp Group Click Here
