Apotex Research require Reviewer-Quality Assurance
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: Reviewer-Quality Assurance Apobiologix
• Set up the quality system in accordance with the requirement for Research and Development. Ensures that assigned work is performed in accordance with General and instrument specific SOPs, regulatory requirements, best practices and established safety standards as applicable.
• Ensure IQ/OQ/PQ documentation wherever applicable. Performs audit/review of software validation packages and IQ/OQ documents for systems used within the Molecular characterization facility for biosimilars.
• Revise, implements, and maintains records of Standards Operating Procedures and additional relevant documents for the bio similar facility.
• Performs in process and retrospective audits (both project and system related) to assure compliance to SOPs, regulatory requirements for the biosimilars department as applicable.
• Prepares QA audit reports for all the above audits/surveillances performed within the scope of development requirements.
• Provides technical and regulatory guidance to internal and external stakeholders to ensure overall quality and compliance during development of analytical methods, data analysis and reporting.
• Ensure documentation of general analytical methods and study or product specific methods.
• Participate in setting up electronic data capture system (ELN, LIMS, SDMS, CDS etc). Implement monitoring and approval system.
• Conducts appropriate follow-up and take to completion any unresolved issues as a result of audit findings.
• Assists in the formal training of new and existing QA staff members for both QA and facility audit and procedures.
• Assists in the evaluation of external vendor performance for suitability of future outsourcing activities
• Stays current on changing regulatory trends, policies and practices as they pertain to the conduct of Apobiologix studies both on a national and international level.
• Reports to Team Leader/Group Leader/Manager/Sr. Manager with respect to the operational status and disposition of all matters relating to the operations in the QA unit.
• Works as a member of a team to achieve all outcomes.
• Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence. Demonstrates strong and visible support of our values.
• Performs all work in accordance with all established regulatory compliance and safety requirements.
• All other duties as assigned.
M.Sc. /M. Pharm.
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