QA Technician (DT) - #7462382

Overview

About us:

Insud Pharma is a recognised and respected company in the pharmaceutical and healthcare sector with more than 40 years of history and more than 7,000 employees in 50 countries specialising in the research, development, manufacture and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.

Chemo, industrial area of the Insud Pharma group, is a world leader in R&D and manufacturing of more than 100 value-added active pharmaceutical ingredients and more than 122 medicines with more than 200 different product presentations. Chemo produces its own active pharmaceutical ingredients (API) as well as finished pharmaceutical products (FDF) covering the main therapeutic groups (Cardiology, Gastroenterology, Central Nervous System, Anti-infectives, Respiratory, Women's Health, Endocrinology, Dermatology and Urology).

COMMITMENT TO EQUAL OPPORTUNITIES

Insud Pharma is aware that business management has to be in line 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 legislation on the subject - Organic Law 3/2007, and we do not discriminate against any person on 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.

Responsibilities

Prepare and reviewrelease 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 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.

• Prepare and revision of the API, raw materials, bulk and finish product release specifications.
• Review and approval of the Pharma bulk and packaged batch records.
• Review and approval of the Food supplement bulk and packaged batch records.
• Review and approve documents and sign the certificates of analysis of all batches manufactured for placing on the market or for regulatory purposes on different countries to be marketed.
• Evaluation in the daily task of approving outputs batches to the market provided by the company, inthe final disposal of manufacturedbatches due to problems encountered during the review of batch documentation and production necessities.
• Monitoring deviations reports raised on batchesfor approval.
• Review, maintain and approve all master batch records and its validation on SAP system in order to be able to manufacture according to the marketing authorization.
• Evaluate all requirements/requests madeby the client (documentation request orinformation pertaining to product registration) to be solved.
• Coordinate with SAP (IT) improvements proposed by and for the QA department.
• Evaluate periodically bulk and packaging stock control to decide availability after holding time.
• Support to Customer requests based on TA, MA or Quality issue.
• Manage Quarantine materials based on not conformity report as a part of on going suppliers qualification.

Qualifications

Requirements and personal skills

• Education: University Degree in Pharmacy.
• Languages: Very High level of English and Spanish.
• Experience (years/area): A minimum of 5 years’ experience in similar position. Essential minimum 5 years’ experience on batch release as part of Quality Assurance department in a production pharmaceutical site.
• 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, problem-solving, good organizational skills and persistent.