Pharmaceutical Process Development Associate

2 weeks ago

Brampton, Ontario, Canada SUN PHARMA Full time
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 the impact of results generated through Pharmaceutical Technology Study protocols.
  • Prepare SOPs, 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.
  • 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 (CAPAs).
  • 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 proven 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
  • 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.

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