job specification

In a few words

Position: QA Technician Intern (Systems)

Location: León

Experience: 1 year

Want to know more?

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

The activities of INSUD PHARMA are organized into three synergistic business areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 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.

Ready to be a #Challenger?

What are we looking for?

We are recruiting a new INSUDER as an technician intern to join the QA team at our site based in León.

Specific Responsibilities

• Develop standard operating procedures (general quality and departmental) to ensure that the steps are collected in each case and comply with internal and external regulations applicable in each case.

• Review and approved internal SOPs

• Document management, distribution of authorized copies and removal of obsolete copies.

• Manage Change Controls, CAPAs and complaints.

• Manage discrepancies, root cause analysis, management layers and trend analysis.

• Provide initial GMP training program compliance.

• Validation activities related to manufacturing and cleaning processes

• Participate in the approval and certification of suppliers, auditing suppliers of raw materials and material conditioning.

• Develop the APR of different products on schedule.

• Do, review, monitoring the microbiological on equipment, environment of the site and purified water, trend analysis.

• Review and approval of the monitoring of pressures and temperature, done by the Engineering Dpto, of the different areas of the site.

• Conducting of internal audits and participation in external.

• Support external audits and inspections according to the Annual Plan to assess the quality of the GMP system.

• Review and coordinate with Production and Engineering/Maintenance the qualification of equipment and systems for complying with GMPs.

• Management of the quality technical agreements between the company and the customers.

• Management of suppliers and third parties. Support to Customer requests based on QTA, MA and/or Quality issues.

• Support to the qualified person

• Support on quality investigations and recalls.

• Management of GMP documentations and related archive

Requirements and personal skills

• Education: Degree in Pharmacy or Chemistry or Sciences.

• Languages: Intermediate or high level of English and bilingual in Spanish.

• Experience (years/area): A minimum of 1 year experience in similar position for a junior position.

• Specific Knowledge: Knowledge of quality systems (procedures, training, deviations/non-conformities, complaints, audits support, etc.) in production plants.

• Travels: Not required.

• Personal skills: Good communication skills, proactivity, good working under pressure, team working, problem-solving, good organizational skills and persistent.

Our benefits!

Internship contract.

Attractive salary package.

Life and accident insurance.

Benefits and Savings Club.

⭐ Many more!

What will the Selection process be like? ️

➡️ Stay tuned to your phone and email! The first thing we will likely do is contact you through one of the two channels.

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

➡️ Wait for the result! We care that you feel guided throughout each selection process and know what to expect from us, so we will always try to inform you of the status of the process.

Do you think this offer is not for you?

Follow us on social media like LinkedIn/Instagram and stay tuned for any offers we may release; the opportunity to be a new Insuder is waiting!

#InsudPharma #Challenger #Insuder #InsudTalent