Analyst, Quality Assurance

Hikma Pharmaceuticals; Sintra; Presencial; EUR 28 000 - 36 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Competitive salary

Growth opportunities

Resumo da oferta

Hikma Pharmaceuticals in Portugal is seeking an Analyst, Quality Assurance to join the Quality Assurance Department on-site. Responsibilities include analyzing bulk samples, in-process control during filling, cleaning verification, data entry in daily logs, and verifying production equipment and processes.

The candidate should have a science degree (or equivalent), strong multitasking and attention to detail, English fluency, and solid computer skills, with knowledge of cGMP/FDA regulations.

Qualificações

• Bachelor-like or higher in science; strong analytical mindset.
• Fluent English and good computer skills required.
• Knowledge of cGMP and FDA regulations preferred.

Responsabilidades

• Conducting or verifying analysis of bulk samples.
• Verifying in-process control during batch filling.
• Conducting or verifying cleaning verification for production parts.
• Entering data in daily forms/logs and ensuring accuracy.
• Ensuring equipment and solutions are maintained under validity.
• Sampling finished products for QA testing.
• Performing rounds in production and packaging areas.
• Carrying out inspections in production areas as needed.
• Assisting start-up before/during production.
• Performing aseptic practices and monitoring cleaning/disinfection.
• Approving maintenance requisitions for production releases.
• Training new QA analysts.
• Verifying prints from production equipment.

Conhecimentos

English fluency

Multitasking

Attention to detail

Computer skills

cGMP knowledge

FDA regulations

Formação académica

High School Diploma or Science degree

Ferramentas

LIMS

Microsoft Office

Descrição da oferta de emprego

Founded by Samih Darwazah over 40 years ago in Jordan, Hikma's purpose is to provide affordable, quality medicines to the people who are competent. Based on very solid foundations, we continue to innovate daily and find practical solutions to transform the lives of the millions of people we serve.

At the end of the 1980s, we extended ours beyond the Middle East and acquired land in Portugal for the construction of a sterile factory for injectable pharmaceutical products. This was an important turning point for the company, and our first step into a new region. Today, in Portugal, we have more than 1000 employees and 3 factories for the production of injectable medicines.

Analyst, Quality Assurance (m/f) to integrate Quality Assurance Department, on-site work.

Main Responsibilities

• Conducting or verifying analysis of bulk sample
• Verifying or conducting sampling and analysis of the in-process control during filling of the batches
• Conducting or verifying analysis after cleaning of machine production parts to verify clean conformity
• Verify or enter the data of the in-process forms/logbook/LIMS on a daily basis and check for accuracy upon request
• Ensures that the equipment's and solutions in use are maintained under validity
• Sample finished product to be tested by the Microbiology and Quality Control Departments
• Performs round checks in production departments, bulk packaging and infrastructures
• Performs inspections in the production areas whenever necessary
• Carries out the start-up before the beginning or during production (whenever necessary)
• Performs Aseptic Practices and Cleaning/ Disinfection Monitoring
• Samples and carries out acceptance procedures in all the different phases of the production, undertakes visual inspection by attributes for defects
• Approves maintenance requisitions for the release of production
• Trains new QA analyst
• Verifies print-outs from equipment related with productions activities

Profile

• High School Diploma or an Academic degree in Science
• Ability to handle a multi-task operation, to meet tight deadlines and to work under pressure
• Should be assertive, flexible, and attentive to detail
• Fluency in English and good computer skills are preferred
• Knowledge regarding the Injectables pharmaceutical industry, current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) and other regulatory authority requirements
• Availability to work 12-hour shifts with rotating days off

We Offer

• Competitive salary aligned with the role
• Real Growth Opportunities

If you think this is a good opportunity for your professional career, join us and contribute to Better Health, within everyone's reach, every day