Position: QA Technician
Location: León
Experience: 1-3 years
INSUD PHARMA operates across the entire pharmaceutical value chain, providing expertise in scientific research, development, manufacturing, sales, and marketing of active pharmaceutical ingredients (API), finished dosage forms (FDF), and branded pharmaceutical products. The company is organized into three synergistic business 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 over 35 subsidiaries, serving 1,150 customers worldwide.
The challenge:
* Prepare and review release specifications, shelf life requirements, and customer requests.
* Review master batch records and ensure their 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, prior to market release.
* Review and sign certificates of analysis.
* Perform periodic stock control checks.
* Manage non-conformities for packaging materials according to European standards and company policies.
All activities must adhere to safety regulations and utilize personal protective equipment as required.
Specific Responsibilities:
* Review and approve specifications for API, raw materials, packaging components, bulk, and finished products.
* Review and approve batch records and related documents.
* Approve analytical data, including handling OOS, OOT, and deviations.
* Issue and approve certificates of analysis for batches and raw materials.
* Approve or reject batches in SAP.
* Monitor deviations, OOS, OOT reports.
* Maintain and approve master batch records in SAP.
* 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 or high level of English; bilingual in Spanish.
* At least 3 years of experience in a similar role for senior positions.
* Extensive knowledge of GMP documentation and quality assurance.
* Proficiency in SAP/R3 and MS Office.
* Willingness to travel occasionally.
* Strong communication, proactivity, pressure management, teamwork, problem-solving, organizational skills, and persistence.
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 social circumstances.
#J-18808-Ljbffr