Vacant job

Job Description

QC-Microbiology is one of three groups within the QC department at our client. The group's mission and area of responsibility include performing microbiological quality controls of raw materials, media, active pharmaceutical ingredients, intermediates, and finished products. Environmental sampling and analysis of clean rooms, reading of vials in connection with media filling in the pharmaceutical manufacturing process, and integrity testing of syringes and vials in connection with projects and stability studies are also part of the assignment. QC MB is also responsible for developing microbiological indicators that are analyzed as part of the qualification and requalification of sterilization equipment and processes within the organization.

As a QC specialist in microbiology, you will be responsible for developing and modernizing existing quality control methods and participating in development projects where you plan and perform technical trials and verifications of microbiological standard methods. You will act as expert support in microbiological methods, represent the organization during inspections, and liaise with external suppliers. Your responsibilities also include ensuring compliance with regulatory requirements, both for internal analyses and those performed by external laboratories, as well as meeting agreed lead times towards internal customers.

Analyses:

Endotoxin analyses

Bioburden

Filtrations, total vialbl

Responsibilities

Coordinate and drive the development of microbiological methods.

Develop validation and verification protocols and perform method validations.

Perform quality control and approve results for products, raw materials, and media.

Coordinate and drive laboratory investigations, manage deviations, CAPA, and change requests.

Act as a technical expert during inspections of external analysis laboratories.

Identify and lead improvement work.

Review analytical results and update internal documents.

Qualifications

University degree in natural sciences, microbiology.

Experience in laboratory operations, preferably within a microbiological laboratory.

Experience in method development and validations.

Fluent in Swedish and English.

Meritorious with experience in GMP-controlled laboratory operations and experience in managing deviations, laboratory investigations, and change requests.

About the Company

Randstad

At Randstad, we know that everyone has a place in the labor market. With operations across the country and in all areas of expertise, we help people find jobs that feel right, where they have the opportunity to grow, develop, and reach their full potential.

With nearly 600,000 employees in 38 countries, Randstad is a world leader in HR services, aiming to be the world's leading and most appreciated partner in the labor market. By combining our passion for people with the power of today's technology, we help people and companies achieve their full potential. We call it Human Forward.