Ténico Transferencias Tecnológicas

Overview:
Global Responsibility

Monitor, prepare and implement protocols/reports for technology transfers, manufacturing guides and provisioning orders, batches registration, industrial lots, working guidelines, documentation and reports and Standard Operational Procedures for Transfer; according to GMP regulations, SOPs, the Pharmacopeia of the various world regions and the guidelines of the manager; in order to ensure the correct execution and updating of the processes at an industrial level.

Responsibilities:
Specific Responsibilities

Coordinate and control the scale-up of new development products in a pilot and industrial scale in conjunction with the Formulation Development and Production area.

Coordinate and control the pilot and industrial escalation of new products already developed.

Coordinate and control the implementation of formula improvements and / or process of existing products.

Coordinate the work necessary to answer to the deficiency letters related to the manufacturing issues.

Coordinate with customers (internal or external) the requirements of the product to be transferred.

Manage and coordinate the necessary work to obtain the documentation of the pharmaceutical registration.

Monitor batch and industrial registration and review the correct implementation of the work guidelines (collecting and analyzing the parameters and results obtained to carry out a report based on the initial protocol, indicating and evaluating comments, conclusions, improvements and deviations) and preparing documentation and reports for the departments of Production and Quality Assurance Records (in case of deviations).

Receive documentation from Formulation Development or the manager (formula and processes) and work (based on this documentation) on human resources, equipment and the results of a first test of scaling (demo batch) and protocols for technology transfers.

Develop manufacturing guidelines and material procurement orders.

Create, monitor, modify and train in the Standard Operating Procedures Transfer (SOPs) to ensure the correct execution and updating of processes.

Open and close change controls, deviations or investigations for each project as necessary.

Work with other departments to ensure identified work items are addressed in a timely and satisfactory manner.

Develops and communicates project timelines and status

Ensure that all activities are fully compliant with all criteria established by governmental agencies, Ministries of Health and legislative requirements

Qualifications:
Requirements and personal skills

Education: Degree in Pharmacy or similar. Master’s Degree in the pharmaceutical field

Languages: Fluent Spanish and English, knowledge of other languages will be an asset.

Experience (years/area): +3 years of experience in a similar position, in formulation, production o tech transfer in the pharma industry.

Specific Knowledge: GMP, GLP, ICH and FDA regulations and Tech Transfer procedures. Knowledge of formulation development (equipment and production processes), Regulatory affairs knowledge. Solid products knowledge.

Travels: Open to travel occasionally.

Personal skills: Ability to work both in a team and autonomously, dynamism and multitasking.

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