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Manager, Formulation Development
Apotex Inc.. Prepare master documents for submission batch execution .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Technical Writing and Formulation Development within the pharmaceutical industry, ensuring compliance with cGMP and regulatory standards while maintaining quality and safety in manufacturing processes.
Highest-signal resume keywords
Technical Writing ExperienceFormulation Development KnowledgeCGMP ComplianceSAP ProficiencyPharmaceutical Manufacturing Processes
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Technical WritingFormulation DevelopmentCGMP PracticesDocumentation ManagementChange ControlQuality System ImplementationInventory ManagementBatch Record PreparationReport GenerationEquipment Maintenance
Soft Skills
Good CommunicationOrganizational CommitmentTeam Support
Tools & Technologies
Microsoft WordMicrosoft ExcelSAP
Industry Keywords
Pharmaceutical TechnologyQuality AssuranceRegulatory ComplianceSafety RequirementsManufacturing Processes
About the role
Key responsibilities & impact- Prepare master documents for submission batch execution
- Prepare master production records and master packing records
- Prepare Exhibit Batch Summary Reports, Hold Study Reports, Photostability Reports, Transportation Worthiness Study Reports, Bulk Product Stability Reports, SOPs, and miscellaneous reports
- Maintain and update inventory of equipment change parts and accessories
- Indent punches, dies, and machine change parts for development and submission batches
- Issue logbooks for new equipment, instruments, punches, and dies
- Prepare SAP purchase indents for raw and packaging materials
- Support subordinates in learning equipment, systems, and processes
- Perform work according to regulatory, compliance, and safety requirements
- Prepare SOPs, formats, protocols, reports, master formulas, SMM, and SPM for the Formulation Development Laboratory
- Maintain and safeguard assigned equipment and company property
- Maintain workplace safety and housekeeping practices
- Practice and upgrade knowledge of cGMP
- Maintain online activity documentation
- Carry out activities assigned by the Research Scientist / Senior Research Scientist
- Produce quality products while following GMP practices and maintaining yields/reducing packaging-material waste
- Coordinate with technicians in other areas and obtain cross-training
- Receive, check, issue, and dispense raw and packaging materials
- Manage Day Stores and Pilot Plant activities, including cGMP, documentation, and departmental quality-system implementation
- Generate and maintain records for raw-material and packaging-material receipt, checking, issue, and dispensing
- Perform other relevant documentation and change-control duties as assigned
Requirements
What you’ll need- University / College degree in Chemistry, Pharmaceutical Technology, or related science preferable B. Pharm/ M Pharm (Pharmaceutics)
- Good communication knowledge of English (Speaking, Reading and Writing)
- Skills in Microsoft Word and Excel
- Working knowledge in SAP
- Knowledge of pharmaceutical manufacturing processes and cGMP is desirable
- Minimum 5 years’ experience in Technical Writing in the pharmaceutical industry/GMP environment
- Overall 6–8 years’ working knowledge of Formulation Development and manufacturing processes in the pharmaceutical industry
- Ability to perform activities in compliance with established procedures
- Commitment to quality and organizational values
- Ability to receive, check, issue, and dispense raw and packaging materials
- Knowledge of documentation, change controls, and departmental quality systems
Benefits
Comp & perks- Accommodation for applicants with disabilities as part of the recruitment process
- Welcoming and accessible work environment
- Supportive and respectful workplace