Managing execution of the annual internal audit plan and guiding internal audit staff in multiple engagements. Focused on ensuring compliance with IA&C policies and best practices.
About the role
- Assistant Manager developing solid oral dosage forms to support Apotex's product pipeline. Leading research and development activities while ensuring compliance with industry regulations.
Responsibilities
- Responsible for developing solid oral dosage forms for assigned projects or product categories by leading development activities to support the company product pipeline.
- Develop experimental approaches and will be responsible for analyzing scientific results from experiments.
- Generating accurate, reliable data by following established procedures and practices to support product development.
- Responsible for formula optimization experiments and process optimization trials by employing the concept of Quality by Design (QbD).
- Create the design space, Identification of Quality Target Product Profile (QTPP), Critical Material Attributes (CMAs), Critical Process Parameters (CPPs) and its effect on drug product Critical Quality Attributes (CQAs).
- Collaborate & participate meetings with multidisciplinary teams to resolve complex product development issues.
- Ensure compliance with current Good Manufacturing Practices (cGMP), Apotex policies and Quality Systems, and all applicable regulatory agencies.
Requirements
- Master’s degree or Ph.D. in Pharmaceutics or Pharmaceutical Technology or related science.
- Excellent working and theoretical knowledge of different pharmaceutical solid oral dosage forms such as immediate release, controlled release & delayed release dosage forms
- Detailed understanding of the theoretical principles for major manufacturing processes and equipment.
- Excellent knowledge of excipient properties and their use in formulation development.
- Strong verbal and written English communication skills.
- Excellent organization and report writing skills.
- Experience using computers, preferable in MS Office (Word, Excel, PowerPoint, Outlook).
- Well-developed interpersonal and team skills.
- Ability to work independently and make responsible and accountable decisions.
- Knowledge of GMP, GLP, GDP, Safety, FDA and TPD guidelines.
- Multi-tasking and project management skills.
- 10-15 years of working experience in a pharmaceutical development environment with related experience in formulation development of solid oral dosage forms for regulated market, scale up and/or technology transfer.
Benefits
- Accommodation for applicants with disabilities as part of its recruitment process
Job title
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