Extractables & Leachables Team Leader

In a nutshell

Position: Extractables and Leachables Team Leader

Experience: at least 5 years in the development of the mentioned functions

Location: Azuqueca de Henares - on-site

Want to know more?👇

INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge and expertise in scientific research, development, manufacturing, sale, and commercialization of a wide range of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, adding value to human and animal health.

INSUD PHARMA's activity is organized into three synergistic business areas: Industrial, Branded, and Biotech, with more than 10,000 professionals in over 50 countries, 20 state-of-the-art facilities, 15 specialized R&D centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development.

Global responsibility

Organize and prioritize project work, determine which assays must be performed and which instrumental equipment must be used. Supervise laboratory personnel to develop efficient analytical methods that allow for the analysis of new products and participate in the resolution of analytical problems. Contribute to project development and document the process and results in reports, in accordance with applicable standard operating procedures (SOP).

Specific responsibilities

• Acquire and anticipate laboratory material needs.
• Supervise and control the correct identification of samples and guarantee their traceability.
• Supervise assays performed by analysts, providing technical support.
• Review documentation associated with each analysis, as well as reports and method validations, to ensure they comply with established protocols.
• Participate in the qualification and calibration of analytical equipment.
• Interpret analytical results, draw conclusions, and define strategies.
• Draft protocols describing how to perform validation assays and prepare the corresponding validation reports, ensuring that the developed methods meet the parameters specified in the ICH (International Council for Harmonisation) guidelines and other applicable guides.
• Investigate Out of Specification (OOS) results and Out of Trend (OOT) results, and complete the associated documentation within the established deadlines.
• Lead investigations to identify the root cause of OOS and OOT results, and propose corrective and preventive actions (CAPA) in collaboration with the Quality Assurance (QA) department.
• Organize and, when necessary, provide training to new analysts.
• Manage the priorities of assigned analytical projects.
• Plan and organize the work of analysts to ensure the obtaining of correct analytical results within the established deadlines, ensuring compliance with good laboratory practices (GLP) and analytical methods.
• Review all documentation generated by analysts.
• Communicate with other departments, such as Purchasing, to gather information on raw materials.
• Stay up to date and continuously review regulatory guidelines applicable to assigned projects.
• Contribute to the design and implementation of practices that guarantee the proper functioning of the laboratory.
• Draft technical standard operating procedures (SOP) when necessary and participate in their continuous review.

Requirements

• Academic background: University degree in Science. Having a master's degree will be positively valued.
• Languages: Upper-intermediate English level.
• Experience (years/area): at least 5 years in the area of extractables and leachables (E&L). Demonstrable knowledge and experience in this field is essential.
• Experience in handling LC-MS, GC-MS, ICP-MS, and IC equipment, as well as the usual equipment used in an extractables and leachables laboratory, is essential.
• Specific knowledge: Experience in environments subject to good manufacturing practices (GMP) will be valued, as well as knowledge of ICH, FDA, and EMA regulatory guidelines.

Our benefits!

⏰Flexible schedule from Monday to Friday with entry from 08:00 to 09:30 and exit from 16:30 onwards depending on the entry time

📜Permanent contract

💸Attractive salary package based on merit

🥼 Life and accident insurance

🍽️ Company canteen (free)

🥼 Co-payment for voluntary health insurance

💸Benefits and Savings Club

📈Development plans, internal mobility policy

⭐And many more!

What will the Selection process be like? 🕵️

➡️Keep an eye on your phone and email! Most likely, the first thing we will do is contact you through one of those two channels.

➡️Prepare well! We will continue with an in-person/virtual interview depending on availability and agreement; there may be between one and two interviews in the process and, depending on the type of process, there may also be some type of test.

➡️Wait for the result! We care that you feel guided in every selection process and know what to expect from us, so we will endeavor to always indicate the status of the process to you.

🔷Do you think this offer is not for you? 🔷

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COMMITMENT TO EQUAL OPPORTUNITIES

The InsudPharma group is aware that business management must be in line with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as set out in the current regulations on the matter - Organic Law 3/2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.