Aseptic Chemical Analyst

JR Italy; Monza; In loco; EUR 35.000 - 60.000; Tempo pieno

Descrizione del lavoro

An established industry player is seeking a dedicated Quality Control Analyst to manage quality control activities for pharmaceutical products. In this pivotal role, you will conduct various analyses on raw materials and finished products, ensuring compliance with established procedures. Your expertise in analytical instrumentation and method validation will be key to maintaining high-quality standards. This position offers an opportunity to collaborate with a skilled team, participate in innovative projects, and contribute to the overall success of the laboratory. If you are detail-oriented and passionate about quality assurance, this role is perfect for you.

Competenze

• Degree in Chemistry or related fields required.
• Previous experience in pharmaceutical quality control laboratory essential.

Mansioni

• Conduct analyses on raw materials and finished products.
• Document analyses and communicate with clients on activity status.

Conoscenze

Analytical Data Evaluation

Attention to Detail

Problem-Solving Skills

Good Command of English

Formazione

Degree in Chemistry

Degree in Chemical Technology

Strumenti

HPLC

GC

LIMS

SAP

Empower System

Descrizione del lavoro

Job Description

Reporting to the Aseptic Chemical Laboratory Manager, the resource will manage quality control activities related to pharmaceutical products in accordance with current plant procedures.

Main activities include:

1. Conducting analyses on raw materials, intermediates, bulk finished products, and packaged finished products, respecting the indicated timelines and recording the operations performed as per the procedures;
2. Performing biochemical analyses (ELISA, Capillary Electrophoresis, etc.);
3. Documenting analyses in laboratory notebooks or in the LIMS system, recording results, compiling certificates of analysis when required, and independently evaluating the analysis results;
4. Collaborating with the supervisor to identify deviations from existing procedures and initiating corrective actions;
5. Verifying the validity expiration of all standards, reagents, and solvents used in the laboratory and ensuring reordering;
6. Participating in projects, serving as the technical reference within the team for all QC aspects;
7. On request from the supervisor, directly communicating with clients to update them on activity status.

Qualifications

• Degree in Chemistry, Chemical Technology, or related fields;
• Previous experience in a pharmaceutical quality control laboratory;
• Minimum experience in method validation, transfer, or verification of compendial and non-compendial methods;
• Excellent knowledge of analytical instrumentation: HPLC, GC, titrators, UV-Vis spectrophotometers, pH meters, viscometers, osmometers, etc.;
• Prior knowledge of the Empower system is preferred;
• Experience or knowledge in biochemistry (ELISA, Capillary Electrophoresis, etc.) is considered a plus;
• Good knowledge of management systems (LIMS and SAP);
• Strong analytical data evaluation skills;
• Good command of the English language, especially reading and writing skills.

Additional Qualities

Strong attention to detail, meticulousness, critical evaluation of analytical data, good GMP knowledge, problem-solving skills, and team-oriented attitude are essential.