QA Technical Department

Role: QA Technical Department

Location: León

Experience: 1–3 years.

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INSUD PHARMA operates across the entire pharmaceutical value chain, providing specialist knowledge and expertise in scientific research, development, manufacturing, sales and marketing of a wide range of active pharmaceutical ingredients (APIs), finished dosage forms (FDFs) and branded pharmaceutical products, adding value to human and animal health.

INSUD PHARMA’s activities are organised into three synergistic business areas: Industrial (Chemo), Branded (Exeltis) and Biotechnology (mAbxience), with over 9,000 professionals in more than 50 countries, 20 state-of-the-art facilities, 15 specialised R&D centres, 12 sales offices and more than 35 pharmaceutical subsidiaries, serving 1,150 customers in 96 countries worldwide. INSUD PHARMA believes in innovation and sustainable development.

Global Responsibility

Suppliers compliance and Management of quality technical agreements in accordance to internal procedures, GMPs rules, Authorities and customers requirements. EU & US GMP compliance. Assure compliance of GMP, regulatory and internal standards according to quality policies and applicable requirements within the organization.

Specific Responsibilities

• Review, negotiate and manage Quality Technical Agreements with customers, suppliers & third parties and services.
• Supplier’s qualification management: risk analysis performance, register update, annual audit plan preparation and follow up, evaluation of the documental compliance, approval and certification status follow up, supplier status update on SAP system.
• Receipt, filling and delivery to customers of quality questionnaires to be filled by QA.
• ICH Q3D and nitrosamine reports review and management
• Elaborate and follow-up self-inspections program and conduct self-inspections.
• Support and external audits and inspections according to assess the quality of the GMP system.
• Develop standard operating procedures (general quality and departmental) to ensure that the steps are collected in each case and comply with internal and external regulations applicable in each case.
• Management of GMP documentations and related archive.
• Support and collaboration with the different activities related to the Qualified Person
• Review and management of quality related registration documents.

Requirements and personal skills

• Education: Degree in Pharmacy or Chemistry or Sciences.
• Languages: Intermediate or high (desirable) level of English required and bilingual in Spanish.
• Experience (years/area): A minimum of 2 years’ experience in similar position for a senior position.
• Specific Knowledge: Knowledge of EU & US GMPs, quality systems (suppliers, quality technical agreement, etc.) in pharmaceutical companies.

Competencies/Career level

• Innovation, customer oriented, communication, team work, adaptability/flexibility, productivity, self-development, sense of urgency, initiative.
• Attention to detail, analytical mindset, compliance mindset, documentation rigor and organizational skills are especially valuable for this position.

COMMITMENT TO EQUAL OPPORTUNITIES

The InsudPharma Group recognises that business management must be aligned with the needs and demands of society, and therefore is committed to equal opportunities and equal treatment for men and women, as set out in the relevant legislation in force – Organic Law 3/2007 – and we do not discriminate against anyone on the grounds of ethnicity, religion, age, sex, nationality, marital status, emotional or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.