Associate, Pharma Tech

General Summary :

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

Principal 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 ( P rocess A nalytical T echnology).
• 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.

Knowledge, Skills and Abilities :

• 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. Working experience with computer spreadsheets and word processing is required.
• Good knowledge and understanding of current Good Manufacturing Practices (c-GMP).

Background and Experience :

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