In a few words
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 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.
The challenge :
Prepare and review release specifications, shelf life requirements, and customer requests; revise master batch records and ensure their validation/compliance in SAP system (BOM / Route); manage GMP deviations related to the site; review and approve manufactured and packaged batches and related analytical data, including OOS if any, prior to market release; review and sign the certificate of analysis; perform periodic stock checks; manage non-conformities for packaging materials according to European standards and quality policy, considering safety regulations and PPE use.
Specific Responsibilities :
* Review and approve API, raw materials, packaging components, bulk and finished product release specifications.
* Review and approve batch records and related documents for bulk and packaged products.
* Review and approve analytical data, including OOS, OOT, and deviations, for industrial products and components.
* Issue, review, and approve certificates of analysis for batches and raw materials.
* Approve or reject batches of products, raw materials, and packaging materials in SAP.
* Monitor deviations / OOS / OOT reports for batch approval.
* Maintain and approve master batch records and their status in SAP according to marketing authorizations.
* Manage GMP documentation and archive.
* Train new team members in position-specific activities and functions.
Requirements and personal skills :
* University Degree in Pharmacy, Chemistry, Biology, or related health sciences.
* Intermediate or advanced English, bilingual in Spanish.
* Minimum 3 years’ experience in a similar QA position for senior roles.
* Extensive knowledge of GMP documentation review and Quality Assurance.
* Familiarity with SAP/R3 and MS Office.
* Willing to travel occasionally.
* Strong communication, proactivity, ability to work under pressure, teamwork, problem-solving, organizational skills, and persistence.
Commitment to Equal Opportunities
INSUD PHARMA is committed to equal opportunities and does not discriminate based on ethnicity, religion, age, sex, nationality, marital status, sexual orientation, gender identity, disability, or other personal circumstances, in line with current regulations.
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