Apotex Research Pvt. Ltd. is a wholly owned subsidiary of Apotex Inc. Canada which is a number one generic pharma co. in Canada. The position is for Bangalore location which has an R&D Centre, Manufacturing and a Bioequivalence Centre.
Post : Research Scientist -Validation
Job Summary
Perform and reporting of Analytical method validations, Analytical method transfers, Archival of analytical method validation documents. Review of validation documents and preparation of validation protocol and reports wherever applicable.
Job Responsibilities
- Responsible for initiation, execution and completion of Analytical method validations and Analytical method transfers.
- Responsible for initiation, execution and completion of Exhibit stability sample analysis, Routine development analysis and Development activities.
- Responsible for all activities in Analytical Research and Development, including cGLP, documentation and implementation of departmental quality systems.
- To assist the Sr Research scientist / Group Leader in the day-to-day functioning of the Analytical Research and Development Laboratory.
- To provide technical support to QC Lab during activities like technology transfers.
- Maintenance and archival of analytical method validation documents.
- Communicating the requirements for the Leaders and within the team members for effective cGLP procedures and departmental quality systems to achieve all outcomes.
- Performing all the activities in support of Apotex Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
- Performing the activities with established regulatory compliance and safety requirements.
- All other duties as assigned.
Candidate Profile
- A graduate/post graduate degree in Chemistry / Pharmacy from a recognized institution.
- Desired candidate should have a minimum of 4 years of experience as a Laboratory Analyst.
- Should be proficient in MS office tools.
- Should have competent verbal & written communication skills.
- Experience of working on online modules / software would be an added advantage.
- Hands on experience in stability Sample testing (Solid Oral Dosage form) and completion within stipulated timeline by following GLP.
- Hands on experience in multimedia dissolution study analysis of test products and innovator products.
- Hands on experience in calibration and qualification of instruments.
- Knowledge on preparation of various documents like SOP’s, Formats, Protocols, Reports, analytical data etc.
- Should possess troubleshooting knowledge on Instruments and analysis.
- Knowledge on Technology Transfers /Method validation.
Other Information:
Experience: 3 to 5 years
Location: Karnataka - Bangalore
Education: M.Pharm, M.Sc, B.Pharm, B.Sc
Industry Type: Pharma/biotech/Clinical research
Functional Area: Validation
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