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Pharmaceutical Process Development Associate

2 months ago


Brampton, Ontario, Canada SUN PHARMA Full time
{"title": "Pharmaceutical Process Development Associate", "content": "Job Summary

The Pharmaceutical Process Development Associate will play a key role in designing, investigating, improving, or troubleshooting current Taro processes. This position requires strong analytical and problem-solving skills, as well as the ability to work effectively in a team environment.

Key Responsibilities
  • Participate in problem-solving, process improvement, and other general issues that may arise in a technology transfer or validation.
  • Responsible for the conceptual design, process development, and technical transfer of new compounding master formulas.
  • Scale-up of R&D batch size to full commercial size using operations equipment, as needed.
  • Prepare investigational lab batches, as required.
  • Investigate and report on possible improvements to existing manufacturing processes.
  • Lead initiatives for cost savings and quality improvements.
  • Write reports that summarize and assess impact of the results generated through Pharmaceutical Technology Study protocols.
  • Prepare SOP's, deviation reports or policies, as needed.
  • Conduct Process Reviews and assess master formula changes for impact to product and validation status.
  • Generate change requests as needed for master formula revisions, improvement initiatives etc.
  • Assist in user specifications, design reviews, purchase specifications, installation and qualification of equipment.
  • Assist in new equipment evaluation and testing as we move towards a PAT approach.
  • As requested, perform analytical tests, interpret results and provide input to improve existing analytical test methods.
  • Complete all GMP Documentation correctly and in a timely manner.
  • Complete all training assignments and maintain personal training records.
  • Participate in and/or lead Non Conformance Investigations.
  • Complete Corrective and Preventive Actions (CAPA's).
  • Initiate, and follow through with actions required to close Change Controls.
  • Participate in Internal, Customer and Regulatory Audits.
Requirements
  • Good understanding of test methods, data interpretation and inference.
  • Good organizational skills and multi-tasking ability.
  • Strong communication skills (written and verbal) and proved ability to work effectively in a team environment.
  • Good computer skills are needed for documentation work, which includes writing of SOPs and technical reports.
  • Good knowledge and understanding of current Good Manufacturing Practices (c-GMP).
  • Post Secondary education is required – Diploma or Degree in a Chemistry, Mechanical Engineering, Chemical Engineering or related discipline.
  • Minimum 3 years of related experience specifically in process development, formulation quality control or quality assurance environment.
  • Experience in a pharmaceutical environment with c-GMP knowledge is preferred.
Working Conditions

A variety of working environments including all areas of the office and plant. Occasional exposure to chemicals and higher or lower than normal temperatures. On occasion working off hours may be required. Some lifting may be required. Routinely a mixture of standing/walking/sitting are required.

", "lang_code": "en-US"}