QA Technician Release - (León Site)

In a few words

Position : QA Techinician.

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; 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, previous to put them on the market; revision and sign the certificate of analysis; periodic stock control check; manage of not conformities form for packaging materials according to European standards and quality policy All this taking into account the safety regulations indicated by the company and the use of personal protective equipment provided depending on the risks of each operation.others.

Specific Responsibilities :

Revision and approval of the API, raw materials, packaging components, bulk and finish product release specifications.

Review and approval of the bulk and packaged batch records and related documents.

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.

Issue, review and approve documents and sign the certificates of analysis of batches manufactured for release or for regulatory purposes on different countries to be marketed.

Issue and approve certificate of analysis related to raw materials.

Approve and / or reject batches of product (bulk and finished), raw materials and packaging materials in SAP system.

Monitoring deviations / OOS / OOT reports raised on batches for approval.

Review, maintain and approve all master batch records and its status on SAP system according to the marketing authorization.

Management of GMP documentations and related archive.

Train the new incorporations in the specific activities and functions of the position in which you are an expert.

Requirements and personal skills :

Education : University Degree in Pharmacy, Chemistry, Biology or Sciences related to Health.

Languages : Intermediate or high level of English and bilingual in Spanish.

Experience (years / area) : A minimum of 3 years’ experience in similar position for a senior position.

Specific Knowledge : Quality Assurance expertise and extensive knowledge on revision of GMP documentation. Knowledge on SAP / R3 and MS Office system.

Travels : Willing to travel occasionally.

Personal skills : Good communication skills, proactivity, good working under pressure, team working, problem-solving, good organizational skills and persistent.

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 - Organic Law 3 / 2007, and we do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.