Position: QA Technician.
Location: León.
Experience: Between 1-3 years.
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 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 (m Abxience), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 R&D centers, 12 commercial offices, and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA emphasizes innovation and sustainable development.
The challenge:
* Prepare and review release specifications, shelf life requirements, and customer requests.
* Revise master batch records and ensure validation/compliance in SAP (BOM/Route).
* Manage GMP deviations related to the site.
* Review and approve manufactured and packaged batches, including analytical data and OOS if any, prior to market release.
* Review and sign certificates of analysis.
* Conduct periodic stock control checks.
* Manage non-conformities for packaging materials according to European standards and quality policies.
All activities must adhere to safety regulations and use personal protective equipment as required.
Specific Responsibilities:
* Review and approve API, raw materials, packaging components, bulk, and finished product specifications.
* Review and approve batch records and related documents.
* Review analytical data, including OOS, OOT, and deviations.
* Issue, review, and approve certificates of analysis for batches and raw materials.
* Approve or reject batches in SAP.
* Monitor deviations/OOS/OOT reports.
* Manage GMP documentation and archives.
* Train new staff in position-specific activities.
Requirements and personal skills:
* University Degree in Pharmacy, Chemistry, Biology, or related health sciences.
* Intermediate/high level of English and bilingual in Spanish.
* Minimum of 3 years’ experience in a similar position for senior roles.
* Knowledge of GMP documentation, SAP/R3, and MS Office.
* Willing to travel occasionally.
* Good communication, proactivity, organizational skills, teamwork, problem-solving, and resilience.
Commitment to equal opportunities: INSUD PHARMA promotes diversity and does not discriminate based on ethnicity, religion, age, sex, nationality, marital status, sexual orientation, gender identity, disability, or other personal circumstances.
The original ad can be found on Kit Empleo: https://www.kitempleo.es/empleo/217096466/j330-technician-release-leon-site-leon/?utm_source=html
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