Title:  Associate, Pharma Tech

Job purpose

The main responsibility of this position is to participate in designing, investigating, improving, or trouble shooting current Taro processes.

Duties and responsibilities

• Participate in problem solving, process improvement, and other general issues that may arise in a technology transfer or validation. This includes trouble shooting existing Taro products; products bought in from outside of Taro, and assist in the process development and commercialization of new Taro products.
• 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.  Where required, recommend corrective measure(s) as needed to obtain a validated status.
• 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 (Process Analytical Technology).
• 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.
• Other duties as assigned.

Qualifications

• 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.
• Good knowledge of Chemistry as it applies to compounding and formulations combined with good understanding of both formulations and manufacturing equipment.
• 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. 

Physical requirements

• Some lifting may be required. 
• Routinely a mixture of standing/walking/sitting are required.

Direct reports

NA