Quality Assurance Inspector

Chemo; León; On-site; EUR 32,000 - 52,000; Full time

Benefits offered by this job

Subsidised canteen

Employee benefits

Job summary

LEONFARMA in León, Spain seeks a packaging GMP specialist to ensure compliance with GMP standards across the packaging process from incoming materials to finished products.

Responsibilities include line clearance, sample archiving for audits, GMP document control, pallet deterioration assessments, packaging design reviews, supplier audits, and material specifications management in a growing international group.

Qualifications

• GMP knowledge or packaging experience.
• English at an intermediate level and bilingual Spanish.
• MS Office and SAP knowledge is a plus.

Responsibilities

• Decide, inform, analyze and review all materials for machine input.
• Archive reference samples for audits and correct storage.
• Find GMP documents needed to address deviations, claims, or issues.
• Inspect deterioration after pallet drops and decide quarantine or disposal.
• Review packaging design to verify internal parameters.
• Manage packaging material specifications.
• Audit packaging suppliers in a GMP environment.

Skills

GMP knowledge

MS Office

Education

High school degree

University degree (plus)

Tools

SAP

Job description

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) and Branded (Exeltis), 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?

Global Responsibility

Comply with the GMP standards for medicinal and combination products for human use.

Check that the finished product complies with the packaging master batch record, GMPs and applicable SOPs for packaging operations. Line clearance performance. Inform about quality issued during packaging activities. Packaging components inspection. Retention samples management.

Specific Responsibilities

• Decide, inform, analyze and review all materials (boxes, leaflets, empty capsules, folding box, aluminum foil, ) that came from Warehouse for introduction into the machine so that the development of the product both at the beginning (encapsulated) and end (boxed) is correct (according to the guidelines manufacturing).
• Archive the reference samples of the finished product and put in chamber for a correct storing to be available in any customer audit.
• Look for and find all GMP doc that is necessary to carry out deviation, claims end critical GMP issues.
• After being informed by warehouse, inspect the deterioration caused by falling pallets in warehouses of finished product (Plant or alternative stores) and decide their validity or their movement to quarantine (destruction), in order to verify compliance of the finished product.
• Review and check packaging design or artwork in order to verify internal parameters.
• Manage packaging material specifications.
• Perform and conduct packaging supplier audits in a GMP environmental.

Requirements and personal skills

• Education: High school degree, University Degree is also a plus.
• Languages: Intermediate or high level of English and bilingual in Spanish.
• Experience (years/area): Basic knowledge of GMP or experience in similar positions.
• Specific Knowledge: MS Office SAP is also a plus.
• Travels: Willing to travel occasionally
• Personal skills: High sense of commitment, achievement and customer orientation, good organizational skills, persistent, good working under pressure.

Career progression and development within a growing international group

Ongoing training and an innovative working environment

Subsidised canteen and other employee benefits

What will the recruitment process be like?

Initial contact by phone or email with our Talent Acquisition team. 1 or 2 face-to-face interviews at our premises in León. Regular updates on the progress of the process.

Do you think this role isn’t for you?

COMMITMENT TO EQUAL OPPORTUNITIES AT LEONFARMA, we believe in and act to promote genuine equality of opportunity. We do not discriminate on the basis of gender, ethnicity, religion, sexual orientation, disability or any other characteristic. We value diversity and talent. We’d love to meet you!