Position: QA Technician.
Location: León.
Experience: Between 1-3 years.
About INSUD PHARMA: 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.
The Challenge: Prepare and review release specifications, shelf life requirements and customer requests; revision of master batch records and its validation/compliance on SAP system (BOM/Route); manage GMP deviations relative to the site; review and approval manufactured and packaged batches and related analytical data, including OOS if any, prior to putting them on the market; revision and sign the certificate of analysis; periodic stock control check; manage non-conformities form for packaging materials according to European standards and quality policy, considering safety regulations indicated by the company.
Specific Responsibilities:
1. Revision and approval of the API, raw materials, packaging components, bulk and finished product release specifications.
2. Review and approval of the bulk and packaged batch records and related documents.
3. Review and approval of the analytical data related to the industrial products and/or components according to the internal SOPs, including OOS, OOT, and deviations.
4. Issue, review and approve documents and sign the certificates of analysis of batches manufactured for release or for regulatory purposes in different countries.
5. Issue and approve certificates of analysis related to raw materials.
6. Approve and/or reject batches of product (bulk and finished), raw materials, and packaging materials in SAP system.
7. Monitoring deviations/OOS/OOT reports raised on batches for approval.
8. Review, maintain, and approve all master batch records and their status on SAP system according to the marketing authorization.
9. Management of GMP documentation and related archive.
10. Train new incorporations in the specific activities and functions of the position.
Requirements and Personal Skills:
1. Education: University Degree in Pharmacy, Chemistry, Biology, or Sciences related to Health.
2. Languages: Intermediate or high level of English and bilingual in Spanish.
3. Experience: A minimum of 3 years’ experience in a similar position for a senior role.
4. Specific Knowledge: Quality Assurance expertise and extensive knowledge on revision of GMP documentation. Knowledge on SAP/R3 and MS Office system.
5. Travels: Willing to travel occasionally.
6. Personal Skills: Good communication skills, proactivity, ability to work under pressure, teamwork, problem-solving, good organizational skills, and persistence.
COMMITMENT TO EQUAL OPPORTUNITIES: The InsudPharma group is aware that business management must align with the needs and demands of society, and therefore assumes the commitment to equal opportunities and treatment between men and women, as stated in the current regulations on the matter.
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