Senior Executive - Manufacturing, Science, And Technologies

Job Summary Site technology Transfer: Internal product technology transfers from an Apotex manufacturing site to Apotex research private limited (ARPL), India. Technology transfer of New products: New product transfer from formulation development to commercial scale. Manufacturing process support: Technical support for the trouble shooting of processing issues in Commercial batch manufacturing. Product Life cycle Management (PLCM): Technical support to ensure robustness of product/process through out its life cycle. Supplier driven changes (SDC): Change or addition of a source or supplier driven change in raw material (API & Excipients) manufacturing process for existing commercial products. Documentation: Documentation support for the MS&T activities. All other relevant duties as assigned. Coordinate, document, and validate manufacturing and packing activities, monitor validation requirements, and support regulatory submissions and product launches/Site transfer.

Requirements

• Master Degree in Pharmacy or Science.
• 2-5 years of experience in GMP Regulated industry.
• Solid dosage process development and technology transfer for regulated markets.
• Strong understanding of product development, scale-up, and process validation.
• Strong understanding of clinical and regulatory requirements for USA, Canada, Australia, EU.
• Good communication and interpersonal skills.
• Computer efficacy in MS-Office and Internet.
• Ability to adapt to frequent changes in priorities and schedules.
• Willingness to upgrade knowledge/education on an on-going basis.

Benefits

• Accommodation for applicants with disabilities.
• Flexible work environment.
• Supportive work environment.