Quality Control Assistant (M/F)

Recipharm AB; Lisboa; Presencial; EUR 25 000 - 35 000; Tempo integral

Resumo da oferta

Recipharm AB is seeking a QC Laboratory professional to join the laboratory team of the QC department. You will execute routine analyses to support the manufacture of the first FDA-approved oral microbiome product, perform sampling and environmental monitoring, and ensure compliance with cGMP.

The role requires a degree in Microbiology or related fields and 1–2 years in the pharmaceutical industry, with flexibility to work in two shifts.

Qualificações

• Degree in Microbiology, Biology, Biotechnology or related field.
• 1–2 years of work experience in pharmaceutical QC.
• Knowledge of Good Manufacturing Practices (cGMP).
• Good command of English.

Responsabilidades

• Perform physiochemical and microbiological analyses for in-process product control per established procedures and cGMP.
• Sample raw materials and packaging materials per established procedures and cGMP.
• Conduct routine environmental monitoring of manufacturing facilities and support areas.
• Sample and analyze water for injectables (WFI) per procedures.
• Support QC investigations on deviations or OOS events.
• Assist QC team in preparing protocols for new assays/methods implementations.
• Ensure QC facilities are clean, organized and continuously monitored.
• Execute routine analyses to support manufacturing of the first FDA-approved oral microbiome product.

Conhecimentos

English

Teamwork

Organizational skills

Shift flexibility

Formação académica

Degree in Microbiology/Biology/Biotechnology or QC

Descrição da oferta de emprego

This person will integrate the laboratory team of the QC department and will report directly to the QC Laboratory Manager. This person willbe responsible forthe execution of routine analysis.

We´re looking for people who have:

• Degree in Microbiology, Biology, Biotechnology or Engineering Sciences (Chemical, Biochemical,Biologicalor similar) or certification in vocational course in QC Microbiology techniques;
• Minimum 1-2 years of work experience in similar roles in pharmaceutical industry;
• Knowledge of Good Manufacturing Practices;
• Strong organizational skills and motivation to work in an innovative industry;
• F lexibilityto work in 2 shifts (8h-15h and 15h-01ham);
• Good team spirit;
• Good knowledge of English.

Technical/Functional Responsibilities:

• Perform the physiochemical and microbiological analysis specificallyrequiredfor in process product control, ensuring compliance with established procedures and current Good Manufacturing Practice (cGMP);
• Perform the sampling of raw materials and packaging materials, ensuring compliance with established procedures and current Good Manufacturing Practice (cGMP);
• Perform routine environmental monitoring of the manufacturing facilities and support areas according to the procedures in place;
• Perform the sampling and analysis of water for injectables (WFI), according to the procedures in place;
• Support QC investigation on deviations or OOS events;
• Support QC team in the preparation of protocols for the implementation of newassays/methods;
• Guarantee Quality Control’sfacilitiescontinuous monitoring, ensuring the laboratories are clean and organized.
• This person will execute routine analyses to support the manufacture of the first FDA-approved oral microbiome product

Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 4,500 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production.

Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden.

For more information on Recipharm and our services, please visit www.recipharm.com and www.recibiopharm.com

URL to this page https://www.recipharm.com/careers/job-search/apply?rmpage=job&rmjob=3736&rmlang=UK