Position: QA Technician
Location: León
Experience: 1-3 years
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INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialized knowledge in research, development, manufacturing, sales, and marketing of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products, contributing to human and animal health.
The activities are organized into three areas: Industrial (Chemo), Branded (Exeltis), and Biotech (mAbxience), with over 9,000 professionals in more than 50 countries, 20 facilities, 15 R&D centers, 12 commercial offices, and 35 subsidiaries, serving 1,150 customers in 96 countries. INSUD PHARMA values innovation and sustainability.
The challenge includes:
* Preparing and reviewing release specifications, shelf life, and customer requests
* Reviewing master batch records and validating them in SAP (BOM/Route)
* Managing GMP deviations
* Reviewing and approving batches and analytical data, including OOS
* Signing certificates of analysis
* Periodic stock checks
* Managing non-conformities for packaging materials per European standards
All activities must adhere to safety regulations and use personal protective equipment as required.
Specific Responsibilities:
* Reviewing and approving API, raw materials, packaging components, and finished products specifications
* Reviewing batch records and related documents
* Reviewing analytical data, including OOS, OOT, deviations
* Issuing and approving certificates of analysis for batches and raw materials
* Approving or rejecting batches in SAP
* Monitoring deviations and reports
* Maintaining master batch records in SAP
* Managing GMP documentation and archives
* Training new staff in position-specific activities
Requirements and personal skills:
* University Degree in Pharmacy, Chemistry, Biology, or related health sciences
* Intermediate to high level of English and bilingual in Spanish
* Minimum 3 years’ experience in a similar role for senior positions
* Knowledge of GMP documentation, SAP/R3, MS Office
* Willing to travel occasionally
* Good communication, proactivity, ability to work under pressure, teamwork, problem-solving, organization, and persistence
Commitment to equal opportunities:
INSUD PHARMA is committed to equality and does not discriminate based on ethnicity, religion, age, sex, nationality, marital or social status, sexual orientation, gender identity, disability, or other personal circumstances.
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