Position: QA Technician
Location: León
Experience: Between 1-3 years
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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). The company employs over 9,000 professionals across more than 50 countries, with 20 state-of-the-art facilities, 15 R&D centers, 12 commercial offices, and more than 35 subsidiaries, serving 1,150 customers worldwide. INSUD PHARMA values innovation and sustainable development.
The challenge:
1. Prepare and review release specifications, shelf life requirements, and customer requests;
2. Review master batch records and ensure validation and compliance in SAP (BOM / Route);
3. Manage GMP deviations related to the site;
4. Review and approve manufactured and packaged batches and analytical data, including OOS, prior to market release;
5. Review and sign certificates of analysis;
6. Conduct periodic stock control checks;
Manage non-conformities related to packaging materials according to European standards and quality policies, ensuring safety regulations and proper use of PPE.
Specific Responsibilities:
* Review and approve API, raw materials, packaging components, bulk, and finished product specifications;
* Review and approve batch records and related documentation;
* Evaluate analytical data, including OOS, OOT, and deviations;
* Issue and approve certificates of analysis for batches and raw materials;
* Approve or reject batches in SAP;
* Monitor deviations and reports on batches;
* Maintain and approve master batch records in SAP;
* Manage GMP documentation and archives;
* Train new team members in position-specific activities.
Requirements and personal skills:
Education: University Degree in Pharmacy, Chemistry, Biology, or related health sciences.
Languages: Intermediate/high level of English and bilingual in Spanish.
Experience: Minimum 3 years in a similar role for senior positions.
Knowledge: Quality Assurance, GMP documentation, SAP/R3, MS Office.
Travel: Willing to travel occasionally.
Personal skills: Good communication, proactivity, ability to work under pressure, teamwork, problem-solving, organizational skills, persistence.
Commitment to equal opportunities: INSUD PHARMA promotes equality and does not discriminate based on ethnicity, religion, age, gender, nationality, marital status, sexual orientation, gender identity, disability, or social circumstances.
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