Apotex Research

The role holder is responsible for supervising and executing the manufacturing operations for Compression, Encapsulation, Coating, and Packing sections in a highly regulated pharmaceutical environment.

Handle, supervise the manufacturing process and related activities of Compounding, Dosing section & Packing

Responsible for execution of the study and system related activities as per the established Standard Operating Procedures, Good Clinical Practices, Good Laboratory Practices and regulatory requirements.

Work both independently and as part of intra, inter-departmental teams to ensure that all work is completed in a timely manner to meet both business and quality standards.

Prepare and provide summary reports for special projects and product evaluations requested by internal or external customers. Review Stability data from third party affiliates for compliance.

Preparation of original DMF, amendments, Annual reports and Review of adequacy of documents for submission. Compilation, review and submission of various Drug master files for US, EU, TGA, Canada and other markets as per respective regulatory guidelines and checklist

Execution of analytical method optimization, development, validation, verification of analytical test methods related to Compendia, In-house developed methods, Site transfer methods, Regulatory queries, Method Life Cycle Management studies, Supplier Driven Changes and other procedural updations.Preparation of method validation/verification protocols and reports.

Physicians, Pharm.D, M.Pharm, Nursing or related Health Science discipline. Excellent analytical and problem-solving skills.

A Post-graduate, Graduate degree in Chemistry, Pharmacy, Life Sciences. Candidate should have knowledge about Post-approval change submission requirement and compilation of variation packages for US, CAN, EU, AUS-NZ, ROW markets.